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OpenTrials
Completed

NCT Number: NCT03596697

A Study in Healthy Volunteers

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.

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Key information

Conditions

Hepatitis B Blood-Borne Infections Communicable Diseases DNA Virus Infections Digestive System Diseases Disease Attributes Hepadnaviridae Infections Hepatitis Hepatitis, Viral, Human Infections Infectious Disease Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Virus Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Celerion, Inc, Tempe, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CRV431

Drug

Single or multiple dose(s) of CRV431

Placebo

Drug

Single Placebo dose

TDF

Drug

Single or multiple dose(s) of TDF

Primary outcomes

  1. Number of healthy volunteers and patients with chronic HBV infection with treatment-related adverse events

    Time frame: 56 days

Sponsors and collaborators

Lead sponsor

Hepion Pharmaceuticals, Inc.

Industry

Registry information

Official study 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 Healthy Volunteer Subjects

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Jul 24, 2018
Registry last updated
Dec 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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