A Study in Healthy Volunteers and Patients With Chronic Hepatitis B

Status:	Active, not recruiting
Conditions:	Infectious Disease, Gastrointestinal, Hepatitis, Hepatitis
Therapuetic Areas:	Gastroenterology, Immunology / Infectious Diseases
Healthy:	No
Age Range:	18 - 55
Updated:	3/6/2019
Start Date:	June 25, 2018
End Date:	June 2019

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 HBV-Infected Subjects on Chronic Tenofovir Disoproxil Fumarate Treatment

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.

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

We found this trial at

sites

Schiff Center for Liver Diseases/University of Miami

Miami, Florida 33136

from

Miami, FL