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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05264038




Registration number
NCT05264038
Ethics application status
Date submitted
28/01/2022
Date registered
3/03/2022

Titles & IDs
Public title
A First in Human Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics Effects of OC514
Scientific title
A Phase 1, Randomized, Double-Blind, Dose-Ranging, Placebo-controlled Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics Effects of OC514 in Healthy Adult Volunteers
Secondary ID [1] 0 0
OC514-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer Cachexia 0 0
Condition category
Condition code
Diet and Nutrition 0 0 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - OC514 (Low dose)
Treatment: Drugs - OC514 (Mid dose)
Treatment: Drugs - OC514 (High dose)
Other interventions - Placebo

Experimental: Cohort 1 - Participants will receive either low dose level of OC514 or placebo

Experimental: Cohort 2 - Participants will receive either mid dose level of OC514 or placebo

Experimental: Cohort 3 - Participants will receive either high dose level of OC514 or placebo


Treatment: Drugs: OC514 (Low dose)
Low dose level of OC514

Treatment: Drugs: OC514 (Mid dose)
Mid dose level of OC514

Treatment: Drugs: OC514 (High dose)
High dose level of OC514

Other interventions: Placebo
Placebo to match
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of treatment-emergent adverse events (TEAEs) and treatment related TEAEs
Timepoint [1] 0 0
Day 1- Day 21
Primary outcome [2] 0 0
Severity of TEAEs and treatment related TEAEs
Timepoint [2] 0 0
Day 1- Day 21
Primary outcome [3] 0 0
Number of participants with abnormal clinically significant laboratory results
Timepoint [3] 0 0
Day 1 - Day 21
Primary outcome [4] 0 0
Number of patients with abnormal vital signs
Timepoint [4] 0 0
Day 1- Day 21
Primary outcome [5] 0 0
Number of participants with abnormal and clinically significant electrocardiogram (ECG)
Timepoint [5] 0 0
Day 1 - Day 21
Primary outcome [6] 0 0
Number of participants with abnormal urinalysis
Timepoint [6] 0 0
Day 1- Day 21
Primary outcome [7] 0 0
Number of participants with abnormal coagulation test
Timepoint [7] 0 0
Day 1- Day 21
Secondary outcome [1] 0 0
Cmax
Timepoint [1] 0 0
Day 1-Day 4, Day 8, Day 16, Day 17
Secondary outcome [2] 0 0
Tmax
Timepoint [2] 0 0
Day 1-Day 4, Day 8, Day 16, Day 17
Secondary outcome [3] 0 0
Cmin
Timepoint [3] 0 0
Day 1-Day 4, Day 8, Day 16, Day 17
Secondary outcome [4] 0 0
AUC (0-last)
Timepoint [4] 0 0
Day 1-Day 4, Day 8, Day 16, Day 17
Secondary outcome [5] 0 0
AUC (0-inf)
Timepoint [5] 0 0
Day 1 and Day 2
Secondary outcome [6] 0 0
AUC (0-12)
Timepoint [6] 0 0
Day 3-Day 16
Secondary outcome [7] 0 0
t1/2
Timepoint [7] 0 0
Day 1-Day 4, Day 8, Day 16, Day 17
Secondary outcome [8] 0 0
?z or Kel
Timepoint [8] 0 0
Day 1-Day 4, Day 8, Day 16, Day 17
Secondary outcome [9] 0 0
CL/F and CL/Fss
Timepoint [9] 0 0
Day 1-Day 4, Day 8, Day 16, Day 17
Secondary outcome [10] 0 0
Vz/F and Vz/Fss
Timepoint [10] 0 0
Day 1-Day 4, Day 8, Day 16, Day 17
Secondary outcome [11] 0 0
Effect of OC514 administration on QT prolongation
Timepoint [11] 0 0
Day 4, Day 8, Day 12, Day 16, Day 17, day 19

Eligibility
Key inclusion criteria
1. Healthy male or female volunteers, between 18 and 65 years of age, both inclusive.
2. BMI between 18 and 32 kg/m2 (inclusive) with a bodyweight >/= 50 kg at screening.
3. Medically healthy with no clinically significant medical history.
4. Adequate venous access.
5. Non-pregnant, non-lactating females.
6. Must be able to comply with the requirements of the study.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. History of any clinically significant disease or disorder.
2. History or presence of gastrointestinal, hepatic, or renal disease or any other condition or past surgical intervention (eg, cholecystectomy).
3. Has creatinine clearance < 60 mL/min.
4. Any current active infections, including localized infections, or any recent history (within 2 weeks prior to first IP administration) of active infections (including severe acute respiratory syndrome coronavirus 2 [SARS-COV-2]), cough or fever, or a history of recurrent or chronic infections.
5. Lymphoma, leukemia, or any malignancy within the past 5 years except for fully resected basal cell or squamous epithelial carcinomas of the skin that have been fully treated for at least 1 year with no recurrence.
6. Any positive laboratory-confirmed COVID-19 test at Screening or check-in.
7. History of human immunodeficiency virus (HIV) antibody positive or tested positive for HIV; had a history of hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV) positive, or other clinically active liver disease, or tested positive for HBsAg or anti-HCV at Screening.
8. Had major surgery (general anesthetic) in the last 3 months or minor surgery (local anesthetic) in the last 1 month prior to Screening.
9. History of narrow angle glaucoma.
10. History of benign prostatic hyperplasia (BPH) with lower urinary tract symptoms.
11. Any clinically significant medical or psychiatric condition, medical/surgical procedure, or trauma within 4 weeks prior to the first IP administration.
12. Blood donation within 1 month of Screening or any blood donation/blood loss greater than 500 mL during the 3 months prior to Screening.
13. Abnormal vital signs.
14. Prolonged Fridericia QT correction formula (QTcF) > 450 msec or shortened QTcF < 340 msec or family history of long QT syndrome at the Screening and on Day -1.
15. Positive screen for drugs of abuse or cotinine (= 500 ng/mL) or positive screen for alcohol at Screening or admission to the CRU on Day -1.
16. History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity, as judged by the Investigator, to any components in the IP.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
3/03/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
13/03/2023
Sample size
Target
Accrual to date
Final
23
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Nucleus network - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Oncocross Australia Pty Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ofer Gonen, Dr.
Address 0 0
Nucleus Network
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05264038