Trials / Completed
CompletedNCT05264038
A First in Human Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics Effects of OC514
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 23 (actual)
- Sponsor
- Oncocross Australia Pty Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | OC514 (Low dose) | Low dose level of OC514 |
| DRUG | OC514 (Mid dose) | Mid dose level of OC514 |
| DRUG | OC514 (High dose) | High dose level of OC514 |
| OTHER | Placebo | Placebo to match |
Timeline
- Start date
- 2022-03-03
- Primary completion
- 2022-09-07
- Completion
- 2023-03-13
- First posted
- 2022-03-03
- Last updated
- 2023-03-20
Locations
1 site across 1 country: Australia
Source: ClinicalTrials.gov record NCT05264038. Inclusion in this directory is not an endorsement.