A Multiple Dose Study of the Safety, Tolerability and PK of CMX157 in Healthy Subjects

A Phase 1, Randomized, Partial-Blind, Placebo-controlled, Sequential Dose Group, Ascending, Multiple Dose Study of the Safety, Tolerability and Pharmacokinetics, With Food Effect, of CMX157 in Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02585440

Enrollment

Registered

2015-10-23

Start date

2016-04-30

Completion date

2016-09-30

Last updated

2017-02-02

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

Conditions

Infectious Disease

Brief summary

This is a phase 1 study to evaluate the safety and tolerability of multiple oral doses of CMX157 at increasing dose levels.

Detailed description

This is a phase 1 study to evaluate the safety and tolerability of multiple oral doses of CMX157 at increasing dose levels, in a fasted state and a fed state.

Interventions

DRUGCMX157

Oral tablet

DRUGplacebo

Oral tablet

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* Age: 18-55. * Capable of giving written informed consent. * Capable of completing study requirements.

Exclusion criteria

* Positive result for HIV, HBV, or HCV. * History or medical condition which could impact patient safety. * Current or past abuse of alcohol or illicit drugs. * Participation in another clinical trial within the past 30 days.

Design outcomes

Primary

Measure	Time frame	Description
Evaluation of the safety and tolerability of multiple oral doses of CMX157 at increasing dose levels.	28 days	Capture adverse events, physical examinations, ECGs and clinical laboratory panels.

Secondary

Measure	Time frame	Description
Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in a fasted state.	28 days	Measuring Cmax: the peak plasma concentration.
Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in a fed state.	28 days	Measuring Cmax: the peak plasma concentration.

Countries

Thailand

Outcome results

None listed

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