Trials / Completed
CompletedNCT04819854
Single and Multiple Ascending Dose Study With EP395
A First-in Man, Phase I Study Investigating the Safety and Tolerability of EP395 in Healthy Volunteers
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 78 (actual)
- Sponsor
- EpiEndo Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Accepted
Summary
This is a study to asses the safety and tolerability of single and multiple ascending doses of EP395, administered by oral capsules, in healthy subjects with the aim to determine the safe dose range of EP395 for further clinical development
Detailed description
This is a study to asses the safety and tolerability of single and multiple ascending doses of EP395, administered by oral capsules, in healthy subjects with the aim to determine the safe dose range of EP395 for further clinical development. The study consists of two parts, part A where single-ascending doses will be assessed and part B where multiple-ascending doses will be assessed. The primary objective being safety and tolerability as well as the pharmacokinetic properties of EP395.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | EP395 | capsule for oral treatment |
| DRUG | Placebo | capsule for oral treatment |
Timeline
- Start date
- 2021-04-05
- Primary completion
- 2022-03-22
- Completion
- 2022-03-22
- First posted
- 2021-03-29
- Last updated
- 2022-03-24
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT04819854. Inclusion in this directory is not an endorsement.