A Study in Healthy Volunteers

Hepion Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Hepatitis B; Infectious Disease; Liver Diseases

Treatments: Drug: Placebo; Drug: CRV431; Drug: TDF

Study type: Interventional

Funder types: Industry

Identifiers

NCT03596697

CTRV-CRV431-101

Details and patient eligibility

About

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.

Enrollment: 92 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

---

92 participants in 3 patient groups, including a placebo group

CRV431

Experimental group

Description:

Either single or multiple doses of varying dose levels

Treatment:

Drug: CRV431

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

TDF

Experimental group

Description:

300 mg TDF

Treatment:

Drug: TDF