Trials / Completed
CompletedNCT04470388
A Study of EDP-514 in Patients With Chronic Hepatitis B Virus Infection Who Are Not Currently on Treatment
A Phase 1b Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of EDP 514 in Viremic Chronic Hepatitis B Virus Infected Patients Not Currently on Treatment
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 25 (actual)
- Sponsor
- Enanta Pharmaceuticals, Inc · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
This is a randomized, double-blind, placebo-controlled study in viremic chronic hepatitis B subjects, assessing the safety, tolerability, pharmacokinetics and antiviral activity of 28 Days treatment with EDP-514.
Detailed description
The study assesses multiple ascending doses of EDP-514 compared to placebo for 28 days in viremic chronic CHB-infected subjects not currently on treatment. Each cohort will enroll a total of 8 subjects who will be randomized to receive EDP-514 or placebo.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | EDP-514 | Oral Capsule |
| DRUG | Placebo | Placebo to match EDP-514 |
Timeline
- Start date
- 2020-09-09
- Primary completion
- 2021-08-30
- Completion
- 2021-08-30
- First posted
- 2020-07-14
- Last updated
- 2022-01-11
Locations
10 sites across 2 countries: Hong Kong, Taiwan
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04470388. Inclusion in this directory is not an endorsement.