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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.
Age
18 - 55 years
Sex
ALL
Healthy Volunteers
Yes
Celerion, Inc
Tempe, Arizona, United States
Celerion, Inc
Lincoln, Nebraska, United States
Pinnacle Clinical Research
San Antonio, Texas, United States
Start Date
July 9, 2019
Primary Completion Date
September 30, 2020
Completion Date
June 4, 2021
Last Updated
December 1, 2021
92
ACTUAL participants
CRV431
DRUG
Placebo
DRUG
TDF
DRUG
Lead Sponsor
Hepion Pharmaceuticals, Inc.
NCT07024641
NCT07069400
NCT07347015
Data Source & Attribution
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