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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03596697

Enrollment

Registered

2018-07-24

Start date

2019-07-09

Completion date

2021-06-04

Last updated

2021-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis B, Infectious Disease, Liver Diseases

Keywords

CRV431, Hepatitis B Virus, Hepatitis Virus

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.

Interventions

DRUGCRV431

Single or multiple dose(s) of CRV431

DRUGPlacebo

Single Placebo dose

DRUGTDF

Single or multiple dose(s) of TDF

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026