Phase 2, Multiple Ascending Dose Proof of Concept Study

• Status: Completed
• Trial end date: 2017-07-18
• Target enrollment: 0
• Participant gender: All

Summary

This is a phase 2a study to evaluate the safety and tolerability of multiple oral doses of CMX157 at increasing dose levels.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ContraVir Pharmaceuticals, Inc.
• Treatments: Hexadecyloxypropyl 9-(2-(phosphonomethoxy)propyl)adenine; Tenofovir

Criteria

Inclusion Criteria:

• Capable of giving written informed consent.

• Capable of completing study requirements.

• Chronic hepatitis B positive.

• HBV treatment naïve.

Exclusion Criteria:

• Positive result for HCV(hepatitis C virus), HDV(hepatitis D virus) or HIV(human immunodeficiency virus).

• History or medical condition that could impact patient safety.

• Current or past abuse of alcohol or illicit drugs.

• Abnormal laboratory value or ECG.

• Pregnant or breastfeeding.

• Clinical, histologic or laboratory evidence of significant liver fibrosis or cirrhosis.

• Systemic immunosuppression.

• Received an investigational drug or investigational vaccine within the 90 days prior to the first dose of study drug.