Phase 2, Multiple Ascending Dose Proof of Concept Study

ContraVir Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Infectious Disease

Treatments: Drug: TDF; Drug: CMX157

Study type: Interventional

Funder types: Industry

Identifiers

NCT02710604

CTRV-CMX157-201

Details and patient eligibility

About

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

Full 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.

Enrollment: 62 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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62 participants in 5 patient groups

CMX157 5mg versus TDF

Active Comparator group

Description:

CMX157, 5mg tablet, 28 days versus TDF(tenofovir disoproxil fumerate) 300mg tablet, 28 days

Treatment:

Drug: CMX157

Drug: TDF

CMX157 10mg versus TDF

Active Comparator group

Description:

CMX157, 10mg tablet, 28 days versus TDF 300mg tablet, 28 days

Treatment:

Drug: CMX157

Drug: TDF

CMX157 25mg versus TDF

Active Comparator group

Description:

CMX157, 25mg tablet, 28 days versus TDF 300mg tablet, 28 days

Treatment:

Drug: CMX157

Drug: TDF

CMX157 50mg versus TDF

Active Comparator group

Description:

CMX157, 50mg tablet, 28 days versus TDF 300mg tablet, 28 days

Treatment:

Drug: CMX157

Drug: TDF

CMX157 100mg versus TDF

Active Comparator group

Description:

CMX157, 100mg tablet, 28 days versus TDF 300mg tablet, 28 days

Treatment:

Drug: CMX157

Drug: TDF