Clinical Trials

CRV431

A Study in Healthy Volunteers and Patients With Chronic Hepatitis B (ClinicalTrials.gov Identifier: NCT03596697)

Overview

Title: 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

Condition: Infectious Disease

Interventions: CRV431, Placebo, TDF (Viread®)

Objectives

Part 1: To assess the safety, tolerability, and PK of a single dose of CRV431 in healthy volunteers

Part 2: Single dose drug-drug interaction study in healthy volunteers with CRV431 co-treated with TDF

Part 3: A multiple ascending dose study of CRV431 administered daily for 28 days in virally suppressed HBV-infected patients; one of the dosing cohorts will include patients with moderate liver fibrosis; the primary purpose of this study is to evaluate safety, tolerability and pharmacokinetics following multiple doses of CRV431; although this is only a 28-day study, analysis of certain biomarkers will be included to evaluate efficacy signals

Outcomes

  • Parts 1 and 2 trials completed successfully
  • Part 3 has not yet been completed
  • The collective data from the Parts 1 and 2 demonstrate a favorable pharmacological, pharmacokinetic, and safety profile for CRV431
  • Clinical findings to date support the proposed further clinical development program of CRV431