drugset / Trial / NCT03596697
A Study in Healthy Volunteers
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | rencofilstat | Small molecule | — | — |
| Background | TDF | Unknown | 300 mg | — |