Study of AT-527 in Healthy Subjects (R07496998)

Study Overview
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Brief Summary
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This study will assess the safety, tolerability and pharmacokinetics (PK) of AT-527 in healthy subjects.

Official Title
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A Phase I Study Assessing the Safety and Pharmacokinetics of Multiple Doses of AT-527 in Healthy Subjects

Conditions
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Healthy Volunteer Study

Intervention / Treatment
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* Drug: AT-527 Formulation 1
* Other: Placebo Comparator
* Drug: AT-527 Formulation 2


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must agree to use two methods of birth control from Screening through 90 days after administration of the last dose of study drug Females must have a negative pregnancy test at Screening and prior to dosing Minimum body weight of 50 kg and body mass index (BMI) of 18-32 kg/m2 Willing to comply with the study requirements and to provide written informed consent Exclusion Criteria: Pregnant or breastfeeding Infected with hepatitis B virus, hepatitis C virus, HIV or COVID-19 Abuse of alcohol or drugs Use of other investigational drugs within 28 days of dosing Other clinically significant medical conditions or laboratory abnormalities

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AT-527 Formulation 1 Dose 1<br> | Drug: AT-527 Formulation 1<br>* AT-527 Formulation 1 (R07496998)<br>Other: Placebo Comparator<br>* Placebo Comparator<br>|
| Experimental: AT-527 Formulation 2 Dose 1<br> | Drug: AT-527 Formulation 2<br>* AT-527 Formulation 2 (R07496998)<br>|
| Experimental: AT-527 Formulation 2 Dose 2<br> | Other: Placebo Comparator<br>* Placebo Comparator<br>Drug: AT-527 Formulation 2<br>* AT-527 Formulation 2 (R07496998)<br>|
| Experimental: AT-527 Formulation 1 Dose 3<br> | Drug: AT-527 Formulation 1<br>* AT-527 Formulation 1 (R07496998)<br>Other: Placebo Comparator<br>* Placebo Comparator<br>|
| Experimental: AT-527 Formulation 2 Dose 3<br> | Other: Placebo Comparator<br>* Placebo Comparator<br>Drug: AT-527 Formulation 2<br>* AT-527 Formulation 2 (R07496998)<br>|
| Experimental: AT-527 Formulation 2 Dose 1 Fast/Fed<br> | Drug: AT-527 Formulation 2<br>* AT-527 Formulation 2 (R07496998)<br>|
| Experimental: AT-527 Formulation 2 Dose 3 Fast/Fed<br> | Drug: AT-527 Formulation 2<br>* AT-527 Formulation 2 (R07496998)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportions (active vs. placebo) of subjects experiencing treatment-emergent adverse events. |  | Day 10 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK) of AT-527 | Maximum plasma concentration (Cmax) | Days 1 and 5 | 
| Pharmacokinetics (PK) of AT-527 | Area under the concentration-time curve (AUC) | Days 1 and 5 |