Phase 2, Multiple Ascending Dose Proof of Concept Study

A Phase 2, Randomized, Open-label, Ascending, Sequential Dose Group, Multiple Dose Study of the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of CMX157 in HBV-infected Subjects

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02710604

Enrollment

Registered

2016-03-17

Start date

2016-05-31

Completion date

2017-07-18

Last updated

2017-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infectious Disease

Keywords

chronic hepatitis B(CHB)

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.

Interventions

DRUGCMX157

tablet

DRUGTDF

300mg tablet

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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: 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: 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: Cmin.	28 days	Measuring Cmin(concentration minimum): minimum observed plasma concentration.

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026