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

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

Detailed Description
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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.

Official Title
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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

Conditions
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Infectious Disease

Intervention / Treatment
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* Drug: CMX157
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>CMX157, tablet, 5 mg, QD, 14 days versus CMX157 placebo, 5 mg, tablet, QD, 14 days | Drug: CMX157<br>* Oral tablet<br>* Other names: Lipid Conjugate TFV;Drug: placebo<br>* Oral tablet<br>|
| Experimental: Group B<br>CMX157, tablet, 10 mg, QD, 14 days versus CMX157, placebo tablet, 10 mg, QD, 14 days | Drug: CMX157<br>* Oral tablet<br>* Other names: Lipid Conjugate TFV;Drug: placebo<br>* Oral tablet<br>|
| Experimental: Group C<br>CMX157, tablet, 25 mg, QD, 14 days versus placebo CMX157, placebo tablet, 25 mg, QD, 14 days | Drug: CMX157<br>* Oral tablet<br>* Other names: Lipid Conjugate TFV;Drug: placebo<br>* Oral tablet<br>|
| Experimental: Group D<br>CMX157, tablet, 50 mg, QD, 14 days versus CMX157, placebo tablet, 50 mg, QD, 14 days | Drug: CMX157<br>* Oral tablet<br>* Other names: Lipid Conjugate TFV;Drug: placebo<br>* Oral tablet<br>|
| Experimental: Group E<br>CMX157, tablet, 100 mg, QD, 14 days versus CMX157, placebo tablet, 100 mg, QD, 14 days | Drug: CMX157<br>* Oral tablet<br>* Other names: Lipid Conjugate TFV;Drug: placebo<br>* Oral tablet<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in a fasted state. | Measuring Cmax: the peak plasma concentration. | 28 days | 
| Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in a fed state. | Measuring Cmax: the peak plasma concentration. | 28 days | 
| Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in a fasted state. | Measuring Tmax: the time Cmax was observed. | 28 days | 
| Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in a fed state. | Measuring Tmax: the time Cmax was observed. | 28 days | 
| Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in a fasted state. | Measuring AUC: area under the plasma concentration versus time curve. | 28 days | 
| Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in a fed state. | Measuring AUC: area under the plasma concentration versus time curve. | 28 days | 
| Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in a fasted state. | Measuring Cmin: minimum observed plasma concentration. | 28 days | 
| Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in a fed state. | Measuring Cmin: minimum observed plasma concentration. | 28 days |