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A Study in Healthy Volunteers

NCT03596697 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2021-12-01

No results posted yet for this study

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.

Conditions

Interventions

DRUG

CRV431

Single or multiple dose(s) of CRV431

DRUG

Placebo

Single Placebo dose

DRUG

TDF

Single or multiple dose(s) of TDF

Sponsors & Collaborators

  • Hepion Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Jill Greytok · ContraVir Pharmaceutical, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-07-09
Primary Completion
2020-09-30
Completion
2021-06-04
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03596697 on ClinicalTrials.gov