Phase 2, Multiple Ascending Dose Proof of Concept Study

ContraVir Pharmaceuticals, Inc.62 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Infectious Disease

Interventions

CMX157DRUG

tablet

TDFDRUG

300mg tablet

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

Unnamed facility

Bangkok, Thailand

Outcomes

Primary Outcomes

Evaluation of the safety and tolerability of increasing multiple oral doses of CMX157 in HBV + patients

Capture adverse events, physical examinations, ECGs and clinical laboratory panels

Time frame: 28 days

To evaluate the antiviral activity of CMX157 versus tenofovir disproxil fumarate(TDF).

HBV DNA levels

Time frame: 28 days

Secondary Outcomes

Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in HBV + subjects, Cmax.

Measuring Cmax(concentration maximum): the peak plasma concentration.

Time frame: 28 days

Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in HBV + subjects: Tmax.

Measuring Tmax(time maximum): the time Cmax was observed.

Time frame: 28 days

Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in HBV + subjects: AUC.

Measuring AUC(area under the curve): area under plasma concentration versus time curve.

Time frame: 28 days

Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in HBV + subjects: Cmin.

Measuring Cmin(concentration minimum): minimum observed plasma concentration.

Time frame: 28 days

Data from ClinicalTrials.gov

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