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NCT04008004 · ClinicalTrials.gov registry record · Phase 1
A Study of EDP-514 in Healthy Subjects (Part 1) and Patients With Chronic Hepatitis B Virus Infection (Part 2)
A Phase 1 study, sponsored by Enanta Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 99
- Enrollment target
NCT04008004: Completed Phase 1 study, sponsored by Enanta Pharmaceuticals.
NCT04008004 is a Phase 1 study that has completed, run by Enanta Pharmaceuticals. The registered enrollment target is 99 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04008004, a Phase 1 study, has completed, sponsored by Enanta Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 99 participants
- Enrollment target
Study Summary
Part 1 is a randomized, double-blind, placebo-controlled study. It will assess the safety, tolerability, and pharmacokinetics of single and multiple orally administered doses of EDP-514 in healthy adult subjects. Part 2 is randomized, double -blind, placebo-controlled study including subjects with Hepatitis B Virus. It will assess the safety, tolerability, pharmacokinetics and antiviral activity of 28 Days of orally administered doses of EDP-514 in nucleos(t)ide reverse transcriptase inhibitor (NUC)-Suppressed Patients with Chronic Hepatitis B Virus Infection
Interventions
- DRUG Placebo
- DRUG EDP-514
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 99 participants |
| Start Date | 2019-06-26 |
| Est. Completion | 2021-07-14 |
| Phase | Phase 1 |
What the finished NCT04008004 record still lists
NCT04008004 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 99 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04008004 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04008004 about?
NCT04008004 is a clinical study titled "A Study of EDP-514 in Healthy Subjects (Part 1) and Patients With Chronic Hepatitis B Virus Infection (Part 2)". Part 1 is a randomized, double-blind, placebo-controlled study. It will assess the safety, tolerability, and pharmacokinetics of single and multiple orally administered doses of EDP-514 in healthy adult subjects. Part 2 is randomized, double -blind, placebo-controlled study including subjects with ...
What is the current status of trial NCT04008004?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 99 participants. The study started on 2019-06-26. Estimated completion is 2021-07-14.
What interventions are being tested in trial NCT04008004?
The interventions under investigation include: Placebo (DRUG), EDP-514 (DRUG).
Who is sponsoring clinical trial NCT04008004?
This trial is sponsored by Enanta Pharmaceuticals, which has 36 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04008004's enrollment target sits among peer trials
99 590th of 2000 higher than 1,409 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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