Phase 2, Multiple Ascending Dose Proof of Concept Study

Phase 2

Completed

• Conditions: Infectious Disease
• Interventions: Drug: CMX157; Drug: TDF

• Registration Number: NCT02710604
• Lead Sponsor: ContraVir Pharmaceuticals, Inc.

Brief Summary

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

Detailed Description

This is a phase 2a study to evaluate the safety and tolerability of multiple oral doses of CMX157 at increasing dose levels in hepatitis B virus(HBV) infected subjects.

Study Timeline

• Study First Submitted: 2016-03-14
• Study First Submitted QC: 2016-03-16
• Study First Posted: 2016-03-17
• Study Start: 2016-05
• Status Verified: 2016-12
• Primary Completion: 2017-07-18
• Study Completion: 2017-07-18
• Last Update Submitted: 2017-09-12
• Last Update Posted: 2017-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CMX157 5mg versus TDF	CMX157	CMX157, 5mg tablet, 28 days versus TDF(tenofovir disoproxil fumerate) 300mg tablet, 28 days
CMX157 5mg versus TDF	TDF	CMX157, 5mg tablet, 28 days versus TDF(tenofovir disoproxil fumerate) 300mg tablet, 28 days
CMX157 10mg versus TDF	CMX157	CMX157, 10mg tablet, 28 days versus TDF 300mg tablet, 28 days
CMX157 10mg versus TDF	TDF	CMX157, 10mg tablet, 28 days versus TDF 300mg tablet, 28 days
CMX157 25mg versus TDF	CMX157	CMX157, 25mg tablet, 28 days versus TDF 300mg tablet, 28 days
CMX157 25mg versus TDF	TDF	CMX157, 25mg tablet, 28 days versus TDF 300mg tablet, 28 days
CMX157 50mg versus TDF	CMX157	CMX157, 50mg tablet, 28 days versus TDF 300mg tablet, 28 days
CMX157 100mg versus TDF	CMX157	CMX157, 100mg tablet, 28 days versus TDF 300mg tablet, 28 days
CMX157 50mg versus TDF	TDF	CMX157, 50mg tablet, 28 days versus TDF 300mg tablet, 28 days
CMX157 100mg versus TDF	TDF	CMX157, 100mg tablet, 28 days versus TDF 300mg tablet, 28 days

Primary Outcome Measures

Name	Time	Method
Evaluation of the safety and tolerability of increasing multiple oral doses of CMX157 in HBV + patients	28 days	Capture adverse events, physical examinations, ECGs and clinical laboratory panels
To evaluate the antiviral activity of CMX157 versus tenofovir disproxil fumarate(TDF).	28 days	HBV DNA levels

Secondary Outcome Measures

Name	Time	Method
Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in HBV + subjects, Cmax.	28 days	Measuring Cmax(concentration maximum): the peak plasma concentration.
Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in HBV + subjects: AUC.	28 days	Measuring AUC(area under the curve): area under plasma concentration versus time curve.
Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in HBV + subjects: Tmax.	28 days	Measuring Tmax(time maximum): the time Cmax was observed.
Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in HBV + subjects: Cmin.	28 days	Measuring Cmin(concentration minimum): minimum observed plasma concentration.