A Study in Healthy Volunteers

Sponsor

Hepion Pharmaceuticals, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT03596697

Collaborator

(none)

Enrollment

Locations

Arms

22.9

Actual Duration (Months)

30.7

Patients Per Site

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis B Infectious Disease Liver Diseases	Drug: CRV431 Drug: Placebo Drug: TDF	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

92 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official 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

Actual Study Start Date :

Jul 9, 2019

Actual Primary Completion Date :

Sep 30, 2020

Actual Study Completion Date :

Jun 4, 2021

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: CRV431

Either single or multiple doses of varying dose levels

Drug: CRV431

Single or multiple dose(s) of CRV431

Placebo Comparator: Placebo

Drug: Placebo

Single Placebo dose

Experimental: TDF

300 mg TDF

Drug: TDF

Single or multiple dose(s) of TDF

Outcome Measures

Primary Outcome Measures

Number of healthy volunteers and patients with chronic HBV infection with treatment-related adverse events [56 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Celerion, Inc	Tempe	Arizona	United States	85283
2	Celerion, Inc	Lincoln	Nebraska	United States	68502
3	Pinnacle Clinical Research	San Antonio	Texas	United States	78229