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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04811469
Registration number
NCT04811469
Ethics application status
Date submitted
16/08/2020
Date registered
23/03/2021
Date last updated
10/08/2022
Titles & IDs
Public title
Safety, Tolerability and Pharmacokinetics of CBP-174 in Healthy Adults
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Scientific title
A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study in Healthy Subjects to Evaluate the Safety, Tolerability, and Pharmacokinetics of CBP-174 After Oral Administration
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Secondary ID [1]
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CBP-174AU001
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Healthy Adult Subjects
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0
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - CBP-174
Treatment: Drugs - Placebo
Experimental: CBP-174 - CBP-174 oral solution
Experimental: Placebo - placebo oral solution
Treatment: Drugs: CBP-174
CBP-174 oral solution, given once
Treatment: Drugs: Placebo
Placebo oral solution, given once
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Incidence of adverse events and serious adverse events
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Assessment method [1]
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Adverse events will be coded according to the Medical Dictionary for Regulatory Activities (MedDRA) Dictionary.
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Timepoint [1]
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Up to 7 days post dosing
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Primary outcome [2]
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Severity of adverse events and serious adverse events
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Assessment method [2]
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The investigator may use the CTCAE V5.0 to assist in the determination of severity and clinical significance.
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Timepoint [2]
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Up to 7 days post dosing
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Primary outcome [3]
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Change in blood pressure
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Assessment method [3]
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Blood pressure measured in mmHg
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Timepoint [3]
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Up to 7 days post dosing
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Primary outcome [4]
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Change in pulse rate
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Assessment method [4]
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Pulse rate measured per minute
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Timepoint [4]
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Up to 7 days post dosing
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Primary outcome [5]
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Change in respiratory rate
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Assessment method [5]
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respiratory rate measured in breaths per minute
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Timepoint [5]
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Up to 7 days post dosing
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Primary outcome [6]
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Change in tympanic temperature
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Assessment method [6]
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tympanic temperature measured in celsius
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Timepoint [6]
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Up to 7 days post dosing
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Primary outcome [7]
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Clinically significant abnormality in physical examinations
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Assessment method [7]
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Physical examinations includes examination in cutaneous, lymph node, head (especially of eyes) and neck, chest, abdomen, musculoskeletal and nervous systems.
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Timepoint [7]
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Up to 7 days post dosing
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Primary outcome [8]
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Clinically significant change in heart rate
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Assessment method [8]
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Heart rate in beats per minute (Bpm) through 12-lead ECG assessment. The Investigator or designee will be responsible for review and interpretation of safety ECGs on site.
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Timepoint [8]
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Up to 7 days post dosing
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Primary outcome [9]
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Clinically significant change in RR interval
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Assessment method [9]
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R-R interval measured in millisecond through 12-lead ECG assessment. The Investigator or designee will be responsible for review and interpretation of safety ECGs on site.
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Timepoint [9]
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Up to 7 days post dosing
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Primary outcome [10]
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Clinically significant change in PR interval
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Assessment method [10]
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P-R interval measured in millisecond through 12-lead ECG assessment. The Investigator or designee will be responsible for review and interpretation of safety ECGs on site.
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Timepoint [10]
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Up to 7 days post dosing
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Primary outcome [11]
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Clinically significant change in QRS complex
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Assessment method [11]
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QRS complex measured in millisecond through 12-lead ECG assessment. The Investigator or designee will be responsible for review and interpretation of safety ECGs on site.
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Timepoint [11]
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Up to 7 days post dosing
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Primary outcome [12]
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Clinically significant change in QT interval
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Assessment method [12]
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QT interval measured in millisecond through 12-lead ECG assessment. The Investigator or designee will be responsible for review and interpretation of safety ECGs on site.
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Timepoint [12]
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Up to 7 days post dosing
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Primary outcome [13]
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Clinically significant change in Fridericia's Correction QT (QTcF) interval
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Assessment method [13]
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QTcF interval measured in millisecond through 12-lead ECG assessment. The Investigator or designee will be responsible for review and interpretation of safety ECGs on site.
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Timepoint [13]
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Up to 7 days post dosing
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Primary outcome [14]
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Clinically significant abnormal laboratory value in Total Protein (TB)
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Assessment method [14]
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Measured in g/dL. The physician will judge whether an abnormality is clinically significant.
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Timepoint [14]
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Up to 7 days post dosing
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Primary outcome [15]
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Clinically significant abnormal laboratory value in Albumin (ALB)
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Assessment method [15]
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Measured in g/dL. The physician will judge whether an abnormality is clinically significant.
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Timepoint [15]
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Up to 7 days post dosing
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Primary outcome [16]
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Clinically significant abnormal laboratory value in Alanine aminotransferase (ALT)
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Assessment method [16]
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Measured in IU/L. The physician will judge whether an abnormality is clinically significant.
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Timepoint [16]
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Up to 7 days post dosing
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Primary outcome [17]
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Clinically significant abnormal laboratory value in Aspartate aminotransferase (AST)
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Assessment method [17]
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Measured in IU/L. The physician will judge whether an abnormality is clinically significant.
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Timepoint [17]
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Up to 7 days post dosing
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Primary outcome [18]
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Clinically significant abnormal laboratory value in Alkaline phosphatase (ALP/AKP)
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Assessment method [18]
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Measured in IU/L. The physician will judge whether an abnormality is clinically significant.
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Timepoint [18]
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Up to 7 days post dosing
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Primary outcome [19]
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Clinically significant abnormal laboratory value in Glutamyl transpeptidase
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Assessment method [19]
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Measured in U/L. The physician will judge whether an abnormality is clinically significant.
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Timepoint [19]
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Up to 7 days post dosing
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Primary outcome [20]
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Clinically significant abnormal laboratory value in Total bilirubin
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Assessment method [20]
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Measured in mg/dL. The physician will judge whether an abnormality is clinically significant.
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Timepoint [20]
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Up to 7 days post dosing
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Primary outcome [21]
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Clinically significant abnormal laboratory value in Direct Bilirubin
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Assessment method [21]
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Measured in mg/dL. The physician will judge whether an abnormality is clinically significant.
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Timepoint [21]
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Up to 7 days post dosing
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Primary outcome [22]
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Clinically significant abnormal laboratory value in Indirect Bilirubin
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Assessment method [22]
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Measured in mg/dL. The physician will judge whether an abnormality is clinically significant.
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Timepoint [22]
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Up to 7 days post dosing
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Primary outcome [23]
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Clinically significant abnormal laboratory value in Blood Glucose
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Assessment method [23]
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Measured in mg/dL. The physician will judge whether an abnormality is clinically significant.
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Timepoint [23]
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Up to 7 days post dosing
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Primary outcome [24]
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Clinically significant abnormal laboratory value in Blood Urea
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Assessment method [24]
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Measured in mg/dL. The physician will judge whether an abnormality is clinically significant.
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Timepoint [24]
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Up to 7 days post dosing
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Primary outcome [25]
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Clinically significant abnormal laboratory value in Blood Uric Acid
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Assessment method [25]
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Measured in mg/dL. The physician will judge whether an abnormality is clinically significant.
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Timepoint [25]
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Up to 7 days post dosing
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Primary outcome [26]
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Clinically significant abnormal laboratory value in Blood Creatinine
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Assessment method [26]
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Measured in mg/dL. The physician will judge whether an abnormality is clinically significant.
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Timepoint [26]
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Up to 7 days post dosing
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Primary outcome [27]
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Clinically significant abnormal laboratory value in Blood Creatine Kinase
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Assessment method [27]
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Measured in IU/L. The physician will judge whether an abnormality is clinically significant.
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Timepoint [27]
0
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Up to 7 days post dosing
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Primary outcome [28]
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Clinically significant abnormal laboratory value in Blood Potassium
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Assessment method [28]
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Measured in mmol/dL. The physician will judge whether an abnormality is clinically significant.
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Timepoint [28]
0
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Up to 7 days post dosing
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Primary outcome [29]
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Clinically significant abnormal laboratory value in Blood Sodium
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Assessment method [29]
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Measured in mmol/dL. The physician will judge whether an abnormality is clinically significant.
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Timepoint [29]
0
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Up to 7 days post dosing
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Primary outcome [30]
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Clinically significant abnormal laboratory value in Blood Chloride
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Assessment method [30]
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Measured in mmol/dL. The physician will judge whether an abnormality is clinically significant.
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Timepoint [30]
0
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Up to 7 days post dosing
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Primary outcome [31]
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Clinically significant abnormal laboratory value in Blood Calcium
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Assessment method [31]
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Measured in mmol/dL. The physician will judge whether an abnormality is clinically significant.
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Timepoint [31]
0
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Up to 7 days post dosing
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Primary outcome [32]
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Clinically significant abnormal laboratory value in Blood Total Cholesterol
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Assessment method [32]
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Measured in mmol/L. The physician will judge whether an abnormality is clinically significant.
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Timepoint [32]
0
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Up to 7 days post dosing
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Primary outcome [33]
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Clinically significant abnormal laboratory value in Blood Triglycerides
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Assessment method [33]
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Measured in mmol/L. The physician will judge whether an abnormality is clinically significant.
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Timepoint [33]
0
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Up to 7 days post dosing
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Primary outcome [34]
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Clinically significant abnormal change in Leukocyte Count
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Assessment method [34]
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Counted in K/uL. The physician will judge whether an abnormality is clinically significant.
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Timepoint [34]
0
0
Up to 7 days post dosing
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Primary outcome [35]
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Clinically significant abnormal change in Neutrophil count
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Assessment method [35]
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Counted in K/uL. The physician will judge whether an abnormality is clinically significant.
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Timepoint [35]
0
0
Up to 7 days post dosing
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Primary outcome [36]
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Clinically significant abnormal change in Lymphocyte count
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Assessment method [36]
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Counted in K/uL. The physician will judge whether an abnormality is clinically significant.
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Timepoint [36]
0
0
Up to 7 days post dosing
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Primary outcome [37]
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Clinically significant abnormal change in Monocytes count
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Assessment method [37]
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Counted in K/uL. The physician will judge whether an abnormality is clinically significant.
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Timepoint [37]
0
0
Up to 7 days post dosing
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Primary outcome [38]
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Clinically significant abnormal change in Eosinophils count
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Assessment method [38]
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Counted in K/uL. The physician will judge whether an abnormality is clinically significant.
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Timepoint [38]
0
0
Up to 7 days post dosing
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Primary outcome [39]
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Clinically significant abnormal change in Basophil count
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Assessment method [39]
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0
Counted in K/uL. The physician will judge whether an abnormality is clinically significant.
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Timepoint [39]
0
0
Up to 7 days post dosing
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Primary outcome [40]
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Clinically significant abnormal change in percentage of Neutrophil
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Assessment method [40]
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0
The physician will judge whether an abnormality is clinically significant.
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Timepoint [40]
0
0
Up to 7 days post dosing
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Primary outcome [41]
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Clinically significant abnormal change in percentage of Lymphocyte
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Assessment method [41]
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0
The physician will judge whether an abnormality is clinically significant.
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Timepoint [41]
0
0
Up to 7 days post dosing
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Primary outcome [42]
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0
Clinically significant abnormal change in percentage of Monocytes
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Assessment method [42]
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0
The physician will judge whether an abnormality is clinically significant.
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Timepoint [42]
0
0
Up to 7 days post dosing
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Primary outcome [43]
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0
Clinically significant abnormal change in percentage of Eosinophils
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Assessment method [43]
0
0
The physician will judge whether an abnormality is clinically significant.
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Timepoint [43]
0
0
Up to 7 days post dosing
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Primary outcome [44]
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0
Clinically significant abnormal change in percentage of Basophils
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Assessment method [44]
0
0
The physician will judge whether an abnormality is clinically significant.
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Timepoint [44]
0
0
Up to 7 days post dosing
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Primary outcome [45]
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Clinically significant abnormal change in Erythrocyte count
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Assessment method [45]
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Counted in K/uL. The physician will judge whether an abnormality is clinically significant.
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Timepoint [45]
0
0
Up to 7 days post dosing
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Primary outcome [46]
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Clinically significant abnormal change in Hemoglobin
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Assessment method [46]
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Measured in mg/dL. The physician will judge whether an abnormality is clinically significant.
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Timepoint [46]
0
0
Up to 7 days post dosing
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Primary outcome [47]
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Clinically significant abnormal change in Hematocrit
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Assessment method [47]
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Measured in %. The physician will judge whether an abnormality is clinically significant.
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Timepoint [47]
0
0
Up to 7 days post dosing
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Primary outcome [48]
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Clinically significant abnormal change in Platelets
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Assessment method [48]
0
0
Counted in K/uL. The physician will judge whether an abnormality is clinically significant.
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Timepoint [48]
0
0
Up to 7 days post dosing
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Primary outcome [49]
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Clinically significant abnormal finding in Urine Occult Blood
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Assessment method [49]
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0
Urine Occult Blood will be record as positive or negative. The physician will judge whether an abnormality is clinically significant.
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Timepoint [49]
0
0
Up to 7 days post dosing
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Primary outcome [50]
0
0
Clinically significant abnormal change in Urine Bilirubin
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Assessment method [50]
0
0
Measured in mg/dL. The physician will judge whether an abnormality is clinically significant.
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Timepoint [50]
0
0
Up to 7 days post dosing
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Primary outcome [51]
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0
Clinically significant abnormal change in Urine pH
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Assessment method [51]
0
0
The physician will judge whether an abnormality is clinically significant.
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Timepoint [51]
0
0
Up to 7 days post dosing
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Primary outcome [52]
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Clinically significant abnormal change in Urine Protein
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Assessment method [52]
0
0
Measured in mg/dL. The physician will judge whether an abnormality is clinically significant.
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Timepoint [52]
0
0
Up to 7 days post dosing
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Primary outcome [53]
0
0
Clinically significant abnormal change in Urine Glucose
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Assessment method [53]
0
0
Measured in mg/dL. The physician will judge whether an abnormality is clinically significant.
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Timepoint [53]
0
0
Up to 7 days post dosing
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Primary outcome [54]
0
0
Clinically significant abnormal change in Urine Specific gravity
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Assessment method [54]
0
0
The physician will judge whether an abnormality is clinically significant.
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Timepoint [54]
0
0
Up to 7 days post dosing
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Primary outcome [55]
0
0
Clinically significant abnormal change in Urine Ketones
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Assessment method [55]
0
0
Measured in mg/dL. The physician will judge whether an abnormality is clinically significant.
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Timepoint [55]
0
0
Up to 7 days post dosing
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Primary outcome [56]
0
0
Clinically significant abnormal change in Urobilinogen
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Assessment method [56]
0
0
Measured in mg/dL. The physician will judge whether an abnormality is clinically significant.
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Timepoint [56]
0
0
Up to 7 days post dosing
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Primary outcome [57]
0
0
Clinically significant abnormal change in Urinary leukocyte
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Assessment method [57]
0
0
Urinary leukocyte will be counted in K/uL. The physician will judge whether an abnormality is clinically significant.
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Timepoint [57]
0
0
Up to 7 days post dosing
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Primary outcome [58]
0
0
Clinically significant abnormal change in Urine erythrocytes
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Assessment method [58]
0
0
Urine erythrocytes will be counted in K/uL. The physician will judge whether an abnormality is clinically significant.
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Timepoint [58]
0
0
Up to 7 days post dosing
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Primary outcome [59]
0
0
Clinically significant abnormal change in Urine Nitrites
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Assessment method [59]
0
0
Measured in mg/dL. The physician will judge whether an abnormality is clinically significant.
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Timepoint [59]
0
0
Up to 7 days post dosing
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Primary outcome [60]
0
0
Clinically significant abnormal change in Prothrombin time (PT)
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Assessment method [60]
0
0
Measured in seconds by coagulation tests. The physician will judge whether an abnormality is clinically significant.
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Timepoint [60]
0
0
Up to 7 days post dosing
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Primary outcome [61]
0
0
Clinically significant abnormal change in Activated partial thromboplastin time (APTT)
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Assessment method [61]
0
0
Measured in seconds by coagulation tests. The physician will judge whether an abnormality is clinically significant.
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Timepoint [61]
0
0
Up to 7 days post dosing
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Primary outcome [62]
0
0
Clinically significant abnormal change in International normalized ratio (INR)
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Assessment method [62]
0
0
The physician will judge whether an abnormality is clinically significant.
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Timepoint [62]
0
0
Up to 7 days post dosing
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Primary outcome [63]
0
0
Clinically significant abnormal change in Fibrinogen (FIB)
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Assessment method [63]
0
0
Measured in mmol/L. The physician will judge whether an abnormality is clinically significant.
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Timepoint [63]
0
0
Up to 7 days post dosing
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Primary outcome [64]
0
0
Clinically significant abnormal change in Thrombin time (TT)
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Assessment method [64]
0
0
Measured in seconds by coagulation tests. The physician will judge whether an abnormality is clinically significant.
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Timepoint [64]
0
0
Up to 7 days post dosing
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Primary outcome [65]
0
0
Clinically significant abnormal in Feces colour
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Assessment method [65]
0
0
The physician will judge whether an abnormality is clinically significant.
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Timepoint [65]
0
0
Up to 7 days post dosing
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Primary outcome [66]
0
0
Clinically significant abnormal in Feces properties
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Assessment method [66]
0
0
The physician will judge whether an abnormality is clinically significant.
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Timepoint [66]
0
0
Up to 7 days post dosing
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Primary outcome [67]
0
0
Clinically significant abnormal in Fecal Red blood cell
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Assessment method [67]
0
0
Measured in Units. The physician will judge whether an abnormality is clinically significant.
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Timepoint [67]
0
0
Up to 7 days post dosing
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Primary outcome [68]
0
0
Clinically significant abnormal in Fecal White blood cell
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Assessment method [68]
0
0
Measured in Units. The physician will judge whether an abnormality is clinically significant.
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Timepoint [68]
0
0
Up to 7 days post dosing
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Primary outcome [69]
0
0
Clinically significant abnormal in Fecal Occult blood
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Assessment method [69]
0
0
Recorded as positive or negative. The physician will judge whether an abnormality is clinically significant.
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Timepoint [69]
0
0
Up to 7 days post dosing
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Secondary outcome [1]
0
0
AUC0-72 h: Area under the plasma concentration-time curve of CBP-174 from time 0 to 72h
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Assessment method [1]
0
0
Calculated by non-compartmental analysis with WinNonlin (Version 8.3.1 or above)
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Timepoint [1]
0
0
Up to 72 hours post dosing
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Secondary outcome [2]
0
0
AUC0-8: Area under the plasma concentration-time curve of CBP-174 from time 0 to infinity
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Assessment method [2]
0
0
Calculated by non-compartmental analysis with WinNonlin (Version 8.3.1 or above)
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Timepoint [2]
0
0
Up to 72 hours post dosing
Query!
Secondary outcome [3]
0
0
Cmax: Maximum observed concentration
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Assessment method [3]
0
0
Calculated by non-compartmental analysis with WinNonlin (Version 8.3.1 or above)
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Timepoint [3]
0
0
Up to 72 hours post dosing
Query!
Secondary outcome [4]
0
0
Tmax: Time to maximum concentration;
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Assessment method [4]
0
0
Calculated by non-compartmental analysis with WinNonlin (Version 8.3.1 or above)
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Timepoint [4]
0
0
Up to 72 hours post dosing
Query!
Secondary outcome [5]
0
0
T1/2: Elimination half-life;
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Assessment method [5]
0
0
Calculated by non-compartmental analysis with WinNonlin (Version 8.3.1 or above)
Query!
Timepoint [5]
0
0
Up to 72 hours post dosing
Query!
Secondary outcome [6]
0
0
?z: Terminal phase rate constant;
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Assessment method [6]
0
0
Calculated by non-compartmental analysis with WinNonlin (Version 8.3.1 or above)
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Timepoint [6]
0
0
Up to 72 hours post dosing
Query!
Secondary outcome [7]
0
0
CL/F: Apparent clearance;
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Assessment method [7]
0
0
Calculated by non-compartmental analysis with WinNonlin (Version 8.3.1 or above)
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Timepoint [7]
0
0
Up to 72 hours post dosing
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Secondary outcome [8]
0
0
V/F: Apparent Volume;
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Assessment method [8]
0
0
Calculated by non-compartmental analysis with WinNonlin (Version 8.3.1 or above)
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Timepoint [8]
0
0
Up to 72 hours post dosing
Query!
Secondary outcome [9]
0
0
%AUCex: Percentage of AUC0-8 obtained by extrapolation
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Assessment method [9]
0
0
Calculated by non-compartmental analysis with WinNonlin (Version 8.3.1 or above)
Query!
Timepoint [9]
0
0
Up to 72 hours post dosing
Query!
Eligibility
Key inclusion criteria
Subjects will be enrolled into the study only if they meet ALL of the following inclusion
criteria:
1. Subjects are fully informed of the study, and are willing to participate in the study
and sign the informed consent document prior to any procedure
2. Healthy male and female subjects, aged 18 to 55 years (both inclusive)
3. Body mass index is between 18 and 32 kg/m2 (both inclusive), the weight of male
subjects = 50 kg, the weight of female subjects = 45 kg
4. Considered generally normal or abnormal with no clinical significance upon medical
history, physical examination, vital signs, ECG, and clinical laboratory tests, as
judged by the Investigator
5. Female subjects of child-bearing potential must agree to use highly effective
contraceptive methods 1 month before the screening, during the entire study, and
within 3 months after the end of this study, and have no egg donation plan within 3
months of study end. The male partner of a female subject must agree to use condoms
during the screening, entire study, and within 3 months after the end of this study.
Male subjects considered fertile must agree to not plan to father a child, donate
sperm, and take effective contraceptive methods during the screening, entire study,
and within 3 months after the end of this study. The female partner of male subjects
must agree to use a highly effective method of female contraception (Section 9.8.3.2)
during the screening, entire study, and within 3 months after the end of this study.
Contraceptive requirements applies to subjects in same sex relationships for male and
female subjects, female subjects of non child bearing potential or male subjects with
female partners of non-childbearing potential.
6. Subjects who are able to communicate well with Investigators, as well as understand
and adhere to the requirements of this study
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Minimum age
18
Years
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Maximum age
55
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Subjects will be excluded from the study, if they meet ANY of the following criteria:
Subjects will be excluded from the study, if they meet ANY of the following criteria:
1. Subjects who have difficulties in venous blood collection or history of dizziness with
blood or needles
2. Female subjects who have a positive pregnancy test or are breastfeeding
3. Subjects who have allergy/hypersensitivity history to any excipient of CBP-174
solution, or hypersensitivity to antihistamines, or severe allergies at the discretion
of Investigator
4. Exposure to any other investigational medicinal product or any other clinical trial
within 30 days or 5 times half-lives (whichever is longer) before dosing current study
medication
5. Subjects who have a history of gastrointestinal (such as duodenal ulcer, alimentary
tract hemorrhage, etc.), liver or kidney disease, or other conditions known to
interfere with the absorption, distribution, metabolism, or excretion of drugs
6. Subjects who have a history of significant eye diseases (such as keratitis, and
scleritis, etc.) or clinical significant eye signs (conjunctiva hyperemia, etc.)
7. Subjects who have a history of attention deficit disorder (ADD) or attention deficit
hyperactivity disorder (ADHD)
8. Subjects who have a history of sleep disorders within 2 years before the screening
visit or score highly on the PSQI or ISI questionaire; or have a history of epilepsy
or other seizure disorder
*Pittsburgh Sleep Quality Index (PSQI) = 8 or Insomnia Severity Index (ISI) = 8
9. Subjects who have the medical history of other significant diseases (including but not
limited to pulmonary, cardiovascular, gastrointestinal, hematological
endocrinological, immunological, dermatological, malignant diseases, mental and
nervous systems, and other related diseases) or any other disease/ailment at the
discretion of the Investigator
10. Subjects with any of the following clinical laboratory tests results at screening:
a Aspartate aminotransferase (AST) > 1.5 × the upper limit of normal (ULN)
b Alanine aminotransferase (ALT) > 1.5 × ULN
c Serum creatinine > 1.2 × ULN; or creatinine clearance < 60 mL/min (calculated by the
Cockcroft-Gault)
*The clinical laboratory tests of hematology, blood biochemistry, or urinalysis could
be allowed repeat once if Investigator considers it necessary
11. Subjects whose QTcF interval prolongation at screening (male: QTcF interval = 450 ms,
female: QTcF interval = 470 ms)
12. Blood donation or blood loss more than 400 mL within 3 months before the screening
visit
13. Subjects with a known history of drug abuse within 2 years before the screening visit;
or positive drug abuse at screening
14. Weekly alcohol consumption of more than 14 units of alcohol (1 unit of alcohol = 360
mL of beer or 45 mL of spirit with the alcohol content of 40% or 150 mL of wine) in
any week within the past 3 months before the screening visit; or intake of
alcohol-containing products within 48 hours before the first dose, or cannot abstain
from any alcohol product during the study, or positive breath alcohol test at
screening or check-in (Day -1)
15. Smoking history (> 5 cigarettes per day) within 3 months before the screening visit,
or cannot abstain from any tobacco products during the study, or positive urine
nicotine test before randomization
16. Excessive drinking of tea, coffee, or caffeine-containing beverage (at least 8 cups
per day, 1 cup = 250 mL) any day within 3 months before screening; intake of rich
caffeine- or xanthine-containing food or drinks that may produce caffeine or xanthine
after being metabolized (eg, coffee, tea, chocolate, cola drinks) within 48 hours
before the first dose
17. Any marketed medication (prescription and nonprescription drugs) within 14 days before
the first dose or within 5 times the elimination half-life or pharmacodynamic
half-life of the medication (excluding oral contraceptives and low dose paracetamol at
the discretion of the Investigator, or topical ointments at the discretion of the
Investigator)
18. Administration of a Coronavirus Disease 2019 (COVID-19) vaccine in the past 14 days
prior to dosing
19. Use of herbal medicines, dietary supplements and vitamin within 14 days before the
first dose(permissible at the discretion of the Investigator)
20. Subjects who have a major surgery within 3 months before the first dose or who plan to
undergo surgery during the study
21. Positive screening test for human immunodeficiency virus (HIV) antibody, hepatitis B
surface antigen (HBsAg), hepatitis B core antibody (HBcAb), or hepatitis C antibody
22. Subjects who are determined as not eligible to participate in this study by the
Investigator
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
24/05/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
21/05/2022
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Sample size
Target
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Accrual to date
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Final
74
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
0
0
Nucleus Network Pty Ltd - Melbourne
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Recruitment postcode(s) [1]
0
0
3004 - Melbourne
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Connect Biopharma Australia Pty Ltd
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of
CBP-174 after a single oral dose in healthy adult subjects.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04811469
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
0
0
Australia Connect
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Address
0
0
Connect Biopharma Australia Pty Ltd
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Country
0
0
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Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for public queries
Name
0
0
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Address
0
0
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Country
0
0
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Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04811469
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