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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/NCT05012423
Registration number
NCT05012423
Ethics application status
Date submitted
22/07/2021
Date registered
19/08/2021
Date last updated
19/08/2021
Titles & IDs
Public title
FTIH Study of ECC0509 in Healthy Volunteers
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Scientific title
A Phase 1, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Single And Multiple Ascending Dose, First-Time-In-Human Study To Assess The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of Ecc0509 In Healthy Volunteers
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Secondary ID [1]
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EC0001
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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:
Nonalcoholic Steatohepatitis
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Osteoarthritis
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Condition category
Condition code
Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Metabolic and Endocrine
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Metabolic disorders
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Diet and Nutrition
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Obesity
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Treatment: Drugs - ECC0509
Treatment: Drugs - Placebo
Treatment: Drugs - ECC0509
Placebo Comparator: SAD Cohorts 1 to 7: Participants Receiving Placebo - Participants in each SAD cohort will be randomized to receive placebo.
Experimental: SAD Cohorts 1 to 7: Participants receiving ECC0509 - Participants in each SAD cohort will be randomized to receive 1 of 7 escalating doses (1 mg, 4 mg, 10 mg, 20 mg, 40 mg, 60 mg, or 80 mg).
Placebo Comparator: MAD Cohorts 1 to 3: Participants receiving Placebo - Participants will be randomized to receive a once-daily dose of placebo for 14 days.
Experimental: MAD Cohorts 1 to 3: Participants receiving ECC0509 - Participants will be randomized to receive a once-daily dose of 1 of 3 escalating doses (8 mg, 20 mg, or 40 mg) for 14 days.
Treatment: Drugs: Placebo
Matching Placebo
Placebo will be administered as oral capsules.
Treatment: Drugs: ECC0509
ECC0509 1 mg and 10 mg capsules
ECC0509 will be administered as oral capsules.
Treatment: Drugs: Placebo
Matching Placebo
Placebo will be given orally during each dosing day.
Treatment: Drugs: ECC0509
ECC0509 1 mg and 10 mg capsules
Placebo will be given orally during each dosing day.
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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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Number of subjects with adverse events and serious adverse events
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Assessment method [1]
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An adverse event is any untoward medical occurrence in a clinical study subject, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Serious adverse event is defined as any untoward medical occurrence that, at any dose that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or other situations as per medical or scientific judgment.
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Timepoint [1]
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SAD: Up to Day 8. MAD: Up to Day 21.
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Primary outcome [2]
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Number of subjects with abnormal values for blood pressure
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Assessment method [2]
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Systolic and diastolic blood pressure of subjects will be measured in a semi-supine position after at least 5 minutes of rest.
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Timepoint [2]
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SAD: Up to Day 8. MAD: Up to Day 21.
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Primary outcome [3]
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Number of subjects with abnormal values for pulse rate
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Assessment method [3]
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Pulse rate of subjects will be measured in a semi-supine or supine position after at least 5 minutes of rest.
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Timepoint [3]
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SAD: Up to Day 8. MAD: Up to Day 21.
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Primary outcome [4]
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Number of subjects with abnormal values for respiratory rate
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Assessment method [4]
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Respiratory rate of subjects will be measured in a semi-supine position after at least 5 minutes of rest.
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Timepoint [4]
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SAD: Up to Day 8. MAD: Up to Day 21.
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Primary outcome [5]
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Number of subjects with abnormal values for tympanic temperature
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Assessment method [5]
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Tympanic temperature of subjects will be measured in a semi-supine position after at least 5 minutes of rest.
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Timepoint [5]
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SAD: Up to Day 8. MAD: Up to Day 21.
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Primary outcome [6]
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Number of subjects with abnormal values for electrocardiogram parameters
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Assessment method [6]
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12-lead electrocardiogram will be obtained using an electrocardiogram machine.
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Timepoint [6]
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SAD: Up to Day 8. MAD: Up to Day 21.
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Primary outcome [7]
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Number of subjects with abnormal findings for clinical chemistry parameters
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Assessment method [7]
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Blood samples will be collected from subjects for analysis of clinical chemistry parameters including urea, potassium, AST, total bilirubin, direct bilirubin, creatinine sodium bicarbonate, chloride, ALT, albumin, glucose, calcium, phosphate, alkaline phosphatase, cholesterol.
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Timepoint [7]
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SAD: Up to Day 8. MAD: Up to Day 21.
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Primary outcome [8]
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Number of subjects with abnormal findings for hematology parameters
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Assessment method [8]
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Blood samples will be collected from subjects for analysis of hematology parameters including platelet count, mean platelet volume, mean cell volume, mean cell hemoglobin, mean corpuscular hemoglobin concentration, white blood cells count, neutrophils, lymphocytes, monocytes, eosinophils, basophils, red blood cells count, hemoglobin and hematocrit.
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Timepoint [8]
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SAD: Up to Day 8. MAD: Up to Day 21.
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Primary outcome [9]
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Number of subjects with abnormal findings for coagulation parameters
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Assessment method [9]
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Blood samples will be collected from subjects for analysis of coagulation parameters including Activated Thromboplastin Time, Prothrombin Time and International Normalized Ratio
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Timepoint [9]
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SAD: Up to Day 8. MAD: Up to Day 21.
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Primary outcome [10]
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Number of subjects with abnormal findings for urinalysis parameters
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Assessment method [10]
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Urine samples will be collected from subjects for analysis of specific gravity, potential of hydrogen (pH) of urine, presence of glucose, protein, blood, ketones, bilirubin, urobilinogen, nitrite, and leukocyte esterase in urine by dipstick test. Microscopic examination will be performed if blood or protein is abnormal.
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Timepoint [10]
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SAD: Up to Day 8. MAD: Up to Day 21.
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Secondary outcome [1]
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Pharmacokinetic assessment 1
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Assessment method [1]
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Area under the plasma concentration versus time curve (AUC)
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Timepoint [1]
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SAD: Up to Day 8. MAD: Up to Day 21.
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Secondary outcome [2]
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Pharmacokinetic assessment 2
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Assessment method [2]
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Peak Plasma Concentration (Cmax)
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Timepoint [2]
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SAD: Up to Day 8. MAD: Up to Day 21.
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Secondary outcome [3]
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Pharmacokinetic assessment 3
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Assessment method [3]
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Time of peak plasma concentration (Tmax)
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Timepoint [3]
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SAD: Up to Day 8. MAD: Up to Day 21.
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Secondary outcome [4]
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Pharmacokinetic assessment 4
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Assessment method [4]
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Half life (T1/2)
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Timepoint [4]
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SAD: Up to Day 8. MAD: Up to Day 21.
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Secondary outcome [5]
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Pharmacokinetic assessment 5
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Assessment method [5]
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Apparent total clearance after oral administration (Cl/F)
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Timepoint [5]
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SAD: Up to Day 8. MAD: Up to Day 21.
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Secondary outcome [6]
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Pharmacokinetic assessment 6
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Assessment method [6]
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Apparent volume of distribution during terminal phase after oral administration (Vz/F)
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Timepoint [6]
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SAD: Up to Day 8. MAD: Up to Day 21.
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Secondary outcome [7]
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Pharmacodynamic assessment
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Assessment method [7]
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Plasma Semicarbazide-Sensitive Amine Oxidase (SSAO) Activity
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Timepoint [7]
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SAD: Up to Day 8. MAD: Up to Day 21.
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Eligibility
Key inclusion criteria
Key
1. Healthy male or non-childbearing potential female
2. Age =18 and =65 years old
3. BMI =18.0 and =32.0 kg/m2
4. Male participants agree to use contraception
5. No clinically significant abnormal findings in physical examination, 12-lead
electrocardiogram (ECG), laboratory tests, or medical history
6. Able to understand and sign informed consent
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Minimum age
18
Years
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Maximum age
65
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
1. Significant allergic reactions to any drug.
2. History of significant drug abuse or alcohol abuse within 1 year prior to screening
3. Concomitant participation in any investigational study of any nature
4. Use of any concomitant medication except for the occasional use of acetaminophen (up
to 2 g daily)
5. Donation of plasma within 7 days prior to dosing or donation or loss of 500 mL or more
of whole blood within 8 weeks prior to dosing.
6. Any clinically significant abnormal findings in the participant's physical
examination, laboratory tests, pregnancy test, urine drug screen, alcohol breath test,
or medical history which, in the opinion of the Investigator, would prevent the
subject from participating in the study.
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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 analysing the results/data
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Intervention assignment
Other
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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
Unknown status
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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
7/07/2021
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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
20/02/2022
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Actual
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Sample size
Target
86
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
SA
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Recruitment hospital [1]
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CMAX Clinical Research - Adelaide
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Recruitment postcode(s) [1]
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5000 - Adelaide
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Eccanga Pty Ltd
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Syneos Health
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
A Phase 1, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Single And Multiple
Ascending Dose, First-Time-In-Human Study to Assess The Safety, Tolerability,
Pharmacokinetics, and Pharmacodynamics of ECC0509 in Healthy Volunteers.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05012423
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Participant Engagement Manager
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Address
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Country
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Phone
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1800150433
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05012423
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