A Study in Healthy Volunteers

November 30, 2021 updated by: Hepion Pharmaceuticals, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

92

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tempe, Arizona, United States, 85283
        • Celerion, Inc
    • Nebraska
      • Lincoln, Nebraska, United States, 68502
        • Celerion, Inc
    • Texas
      • San Antonio, Texas, United States, 78229
        • Pinnacle Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 51 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Single Placebo dose
Experimental: CRV431
Either single or multiple doses of varying dose levels
Drug: CRV431
Single or multiple dose(s) of CRV431
Experimental: TDF
300 mg TDF
Drug: TDF
Single or multiple dose(s) of TDF

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hepion Pharmaceuticals, Inc.

Investigators

  • Study Director: Jill Greytok, ContraVir Pharmaceutical, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 9, 2019

Primary Completion (Actual)

September 30, 2020

Study Completion (Actual)

June 4, 2021

Study Registration Dates

First Submitted

July 3, 2018

First Submitted That Met QC Criteria

July 12, 2018

First Posted (Actual)

July 24, 2018

Study Record Updates

Last Update Posted (Actual)

December 1, 2021

Last Update Submitted That Met QC Criteria

November 30, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTRV-CRV431-101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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