Overview

A Study in Healthy Volunteers

Status:
Recruiting
Trial end date:
2020-07-31
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
ContraVir Pharmaceuticals, Inc.
Hepion Pharmaceuticals, Inc.
Treatments:
Tenofovir
Criteria
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