A Study in Healthy Volunteers

Completed · Phase 1 · Has a placebo group

Conditions studied: Hepatitis B, Infectious Disease, Liver Diseases

In brief

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.

Key facts

Study ID

NCT03596697

Run by

Hepion Pharmaceuticals, Inc.

People needed

92

Starts

2019-07-09

Expected to finish

2021-06-04

Last updated by the study team

2021-12-01

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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);

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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