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NCT03596697 · ClinicalTrials.gov registry record · Phase 1

A Study in Healthy Volunteers

A Phase 1 study, sponsored by Hepion Pharmaceuticals.

Completed
Registry status
Phase 1
Development phase
92
Enrollment target

NCT03596697: Completed Phase 1 study, sponsored by Hepion Pharmaceuticals.

NCT03596697 is a Phase 1 study that has completed, run by Hepion Pharmaceuticals. The registered enrollment target is 92 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03596697, a Phase 1 study, has completed, sponsored by Hepion Pharmaceuticals.

COMPLETED
Registry status
Phase 1
Development phase
92 participants
Enrollment target

Study Summary

This is three part study that will, in part one assess the safety, tolerability, and PK of a single dose of CRV431 in healthy volunteers. The second part of the study will be a single dose drug-drug interaction study in healthy volunteers with CRV431 co-treated with TDF. The third part of the study will assess the safety, tolerability, PK, and preliminary signal for antiviral efficacy and identification of clinically-relevant biomarkers of CRV431 with TDF in stable HBV patients.

Interventions

  • DRUG Placebo
  • DRUG TDF
  • DRUG CRV431

Trial Details

FieldValue
Enrollment Target 92 participants
Start Date 2019-07-09
Est. Completion 2021-06-04
Phase Phase 1
Hepion Pharmaceuticals

4 total trials

What the finished NCT03596697 record still lists

NCT03596697 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 92 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% higher).

The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.

NCT03596697 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03596697 about?

NCT03596697 is a clinical study titled "A Study in Healthy Volunteers". This is three part study that will, in part one assess the safety, tolerability, and PK of a single dose of CRV431 in healthy volunteers. The second part of the study will be a single dose drug-drug interaction study in healthy volunteers with CRV431 co-treated with TDF. The third part of the study ...

What is the current status of trial NCT03596697?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 92 participants. The study started on 2019-07-09. Estimated completion is 2021-06-04.

What interventions are being tested in trial NCT03596697?

The interventions under investigation include: Placebo (DRUG), TDF (DRUG), CRV431 (DRUG).

Who is sponsoring clinical trial NCT03596697?

This trial is sponsored by Hepion Pharmaceuticals, which has 4 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03596697's enrollment target sits among peer trials

92 625th of 2000 higher than 1,375 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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Source: ClinicalTrials.gov NCT03596697, the US trial registry maintained by the National Library of Medicine. NCT03596697 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.