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A Study in Healthy Volunteers

NCT ID: NCT03596697

Last Updated: 2021-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-09

Study Completion Date

2021-06-04

Brief Summary

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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.

Detailed Description

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Conditions

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Hepatitis B Infectious Disease Liver Diseases

Keywords

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CRV431 Hepatitis B Virus Hepatitis Virus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CRV431

Either single or multiple doses of varying dose levels

Group Type EXPERIMENTAL

CRV431

Intervention Type DRUG

Single or multiple dose(s) of CRV431

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Single Placebo dose

TDF

300 mg TDF

Group Type EXPERIMENTAL

TDF

Intervention Type DRUG

Single or multiple dose(s) of TDF

Interventions

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CRV431

Single or multiple dose(s) of CRV431

Intervention Type DRUG

Placebo

Single Placebo dose

Intervention Type DRUG

TDF

Single or multiple dose(s) of TDF

Intervention Type DRUG

Eligibility Criteria

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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.


* Evidence of significant liver fibrosis or cirrhosis
* History of NAFLD or NASH
* Positive test for HDV
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hepion Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jill Greytok

Role: STUDY_DIRECTOR

ContraVir Pharmaceutical, Inc.

Locations

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Celerion, Inc

Tempe, Arizona, United States

Site Status

Celerion, Inc

Lincoln, Nebraska, United States

Site Status

Pinnacle Clinical Research

San Antonio, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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CTRV-CRV431-101

Identifier Type: -

Identifier Source: org_study_id