NCT03596697

A Study in Healthy Volunteers

A Randomized, Partially-blinded, Placebo-controlled, Ascending Sequential Dose Groups, Single Dose Study of the Safety, Tolerability and Pharmacokinetics of CRV431, Alone and In Combination With Tenofovir Disoproxil Fumarate in Healthy Subjects, With a Pilot Study of Multiple Ascending Sequential Doses in Healthy Volunteer Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 92 (actual)
• Sponsor: Hepion Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Hepatitis B
• Infectious Disease
• Liver Diseases

Interventions

Type	Name	Description
DRUG	CRV431	Single or multiple dose(s) of CRV431
DRUG	Placebo	Single Placebo dose
DRUG	TDF	Single or multiple dose(s) of TDF

Timeline

• Start date: 2019-07-09
• Primary completion: 2020-09-30
• Completion: 2021-06-04
• First posted: 2018-07-24
• Last updated: 2021-12-01

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study