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
Overview
- Phase
- Phase 1
- Intervention
- OC514 (Low dose)
- Conditions
- Cancer Cachexia
- Sponsor
- Oncocross Australia Pty Ltd.
- Enrollment
- 23
- Locations
- 1
- Primary Endpoint
- Number of participants with abnormal clinically significant laboratory results
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
Oncocross is developing OC514, a drug-drug combination product containing 2 active pharmaceutical ingredients for cancer cachexia. This study is designed to assess the safety and tolerability of single and multiple oral doses of OC514 in healthy adult volunteers.
Detailed Description
This is a single-center study in which a total of 24 subjects will be enrolled into 1 of 3 dose level cohorts in an ascending fashion. Each cohort will consist of 8 subjects randomized to receive OC514 or matching placebo at a ratio of 3:1. Eligible subjects will be admitted to the clinical research unit (CRU) from Day -1 to 5 and again from Day 15 to Day 17 and will be discharged upon completion of post-dose assessment. The subjects will attend the CRU for outpatients visits on Day 8 and Day 12. The subjects will return for a follow-up visit on Day 19 and End of Study visit on Day 21. The total study duration is up to 9 weeks consisting of up to 6 weeks of screening, 2 weeks of blinded treatment, and 1 week of safety follow-up. Safety oversight will be provided by a Safety Review Committee (SRC).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy male or female volunteers, between 18 and 65 years of age, both inclusive.
- •BMI between 18 and 32 kg/m2 (inclusive) with a bodyweight \>/= 50 kg at screening.
- •Medically healthy with no clinically significant medical history.
- •Adequate venous access.
- •Non-pregnant, non-lactating females.
- •Must be able to comply with the requirements of the study.
Exclusion Criteria
- •History of any clinically significant disease or disorder.
- •History or presence of gastrointestinal, hepatic, or renal disease or any other condition or past surgical intervention (eg, cholecystectomy).
- •Has creatinine clearance \< 60 mL/min.
- •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.
- •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.
- •Any positive laboratory-confirmed COVID-19 test at Screening or check-in.
- •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.
- •Had major surgery (general anesthetic) in the last 3 months or minor surgery (local anesthetic) in the last 1 month prior to Screening.
- •History of narrow angle glaucoma.
- •History of benign prostatic hyperplasia (BPH) with lower urinary tract symptoms.
Arms & Interventions
Cohort 1
Participants will receive either low dose level of OC514 or placebo
Intervention: OC514 (Low dose)
Cohort 1
Participants will receive either low dose level of OC514 or placebo
Intervention: Placebo
Cohort 2
Participants will receive either mid dose level of OC514 or placebo
Intervention: OC514 (Mid dose)
Cohort 2
Participants will receive either mid dose level of OC514 or placebo
Intervention: Placebo
Cohort 3
Participants will receive either high dose level of OC514 or placebo
Intervention: OC514 (High dose)
Cohort 3
Participants will receive either high dose level of OC514 or placebo
Intervention: Placebo
Outcomes
Primary Outcomes
Number of participants with abnormal clinically significant laboratory results
Time Frame: Day 1 - Day 21
Clinical laboratory includes hematology, and biochemistry
Number of participants with abnormal urinalysis
Time Frame: Day 1- Day 21
Dipstick test will be performed
Number of treatment-emergent adverse events (TEAEs) and treatment related TEAEs
Time Frame: Day 1- Day 21
TEAEs will be measured as per the Common Terminology Criteria for Adverse Events (CTCAE) v 5.0
Severity of TEAEs and treatment related TEAEs
Time Frame: Day 1- Day 21
TEAEs will be measured as per the Common Terminology Criteria for Adverse Events (CTCAE) v 5.0
Number of patients with abnormal vital signs
Time Frame: Day 1- Day 21
Includes supine systolic and diastolic blood pressure, pulse rate, oxygen saturation, body temperature, and respiratory rate
Number of participants with abnormal and clinically significant electrocardiogram (ECG)
Time Frame: Day 1 - Day 21
12-lead ECG will be taken
Number of participants with abnormal coagulation test
Time Frame: Day 1- Day 21
Prothrombin time, International normalization ratio, Activated partial thromboplastin time
Secondary Outcomes
- AUC (0-inf)(Day 1 and Day 2)
- Cmax(Day 1-Day 4, Day 8, Day 16, Day 17)
- t1/2(Day 1-Day 4, Day 8, Day 16, Day 17)
- CL/F and CL/Fss(Day 1-Day 4, Day 8, Day 16, Day 17)
- Tmax(Day 1-Day 4, Day 8, Day 16, Day 17)
- Cmin(Day 1-Day 4, Day 8, Day 16, Day 17)
- AUC (0-12)(Day 3-Day 16)
- λz or Kel(Day 1-Day 4, Day 8, Day 16, Day 17)
- AUC (0-last)(Day 1-Day 4, Day 8, Day 16, Day 17)
- Vz/F and Vz/Fss(Day 1-Day 4, Day 8, Day 16, Day 17)
- Effect of OC514 administration on QT prolongation(Day 4, Day 8, Day 12, Day 16, Day 17, day 19)