drugset / Trial / NCT03596697

A Study in Healthy Volunteers

NCT03596697 ↗

Phase 1 Completed 92 enrolled Hepion Pharmaceuticals, Inc.
RandomizedSequentialOpen-labelTreatment

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.

Timeline

Start
2019-07-09
Primary completion
2020-09-30
Completion
2021-06-04

Outcome

Met primary endpoint

release “Rencofilstat met the primary endpoints of safety and tolerability in a single ascending dose study of healthy volunteers.” hepionpharma.com ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject rencofilstat Small molecule — —
Background TDF Unknown 300 mg —