A Study in Healthy Volunteers

Phase 1

Completed

• Conditions: Liver Diseases; Hepatitis B; Infectious Disease
• Interventions: Drug: TDF; Drug: CRV431; Drug: Placebo

• Registration Number: NCT03596697
• Lead Sponsor: Hepion Pharmaceuticals, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-07-03
• Study First Submitted QC: 2018-07-12
• Study First Posted: 2018-07-24
• Study Start: 2019-07-09
• Primary Completion: 2020-09-30
• Study Completion: 2021-06-04
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-30
• Last Update Posted: 2021-12-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

Inclusion Criteria

• Capable of giving written informed consent
• Willing and able to complete all study requirements
• Healthy male or female between 18 and 55 years of age (inclusive);
• Body mass index 16 to 32 kg/m2 (inclusive);

Exclusion Criteria

• Positive test for HCVAb or HIVAb. For healthy subjects only: positive test for HBsAg
• Current or history of abuse of alcohol or illicit drugs
• Received an investigational drug, vaccine or medical device within 90 days prior to first dose of study drug.

Additional Exclusion Criteria for HBV Pilot Subjects Only:

• Evidence of significant liver fibrosis or cirrhosis
• History of NAFLD or NASH
• Positive test for HDV

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
TDF	TDF	300 mg TDF
CRV431	CRV431	Either single or multiple doses of varying dose levels
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Number of healthy volunteers and patients with chronic HBV infection with treatment-related adverse events	56 days

Trial Locations

Locations (2)

Pinnacle Clinical Research; 🇺🇸 San Antonio, Texas, United States

Celerion, Inc; 🇺🇸 Lincoln, Nebraska, United States