Study of AT-527 in Healthy Subjects Under Fasting Conditions or With a Meal

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 following oral administration under fasting conditions or with a meal in healthy adult subjects

Official Title
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Phase 1, Multiple Dose, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of AT-527 Following Oral Administration Under Fasting Conditions or With a Meal in Healthy Adult Subjects

Conditions
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Healthy Volunteer Study

Intervention / Treatment
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* Drug: AT-527 fasted
* Other: Placebo Comparator fasted
* Drug: AT-527 fed
* Other: Placebo Comparator fed
* Drug: AT-527
* Drug: AT-527 single dose


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<br> | Drug: AT-527 fasted<br>* AT-527 administered twice daily (BID) for 5 days fasted<br>* Other names: Bemnifosbuvir;Drug: AT-527 fed<br>* AT-527 administered twice daily (BID) for 5 days fed<br>* Other names: Bemnifosbuvir;|
| Placebo Comparator: Placebo<br> | Other: Placebo Comparator fasted<br>* Matching placebo administered twice daily (BID) for 5 days fasted<br>Other: Placebo Comparator fed<br>* Matching placebo administered twice daily (BID) for 5 days fed<br>|
| Experimental: AT-527 BID<br> | Drug: AT-527<br>* AT-527 administered twice daily (BID)<br>* Other names: Bemnifosbuvir;|
| Experimental: AT-527 single dose fasted/fed<br> | Drug: AT-527 single dose<br>* AT-527 single dose fasted/fed cross-over<br>* Other names: Bemnifosbuvir;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK) of AT-527 | Maximum plasma concentration (Cmax) | Day 1 | 
| Pharmacokinetics (PK) of AT-527 | Area under the concentration-time curve (AUC) | Day 1 | 
| Pharmacokinetics (PK) of AT-527 | Trough plasma concentration (Ctrough) | Day 1 | 
| Proportions of subjects experiencing treatment-emergent adverse events |  | Day 1-10 |