Study of AT-752 in Healthy Subjects

Study Overview
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Brief Summary
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This study will assess the safety, tolerability and pharmacokinetics (PK) of AT-752 in healthy subjects

Detailed Description
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A First-in Human, Randomized, Double-blind, Placebo controlled Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of AT-752 in Healthy Subjects

Official Title
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A First-in Human, Randomized, Double-blind, Placebo Controlled Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of AT-752 in Healthy Subjects

Conditions
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Dengue

Intervention / Treatment
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* Drug: AT-752
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body mass index (BMI) of 18-29 kg/m2 Must agree to use protocol-specified methods of contraception Negative pregnancy test Willing to comply with the study requirements and to provide written informed consent Exclusion Criteria: Pregnant or breastfeeding Abuse of alcohol or drugs Use of other investigational drugs within 30 days of dosing Other clinically significant medical conditions

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: Sequential Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AT-752 250 mg single dose<br>AT-752 administered orally, 250 mg on Day 1 | Drug: AT-752<br>* Parallel Assignment<br>|
| Placebo Comparator: Placebo -single dose<br>Matching placebo administered orally on Day 1 | Drug: Placebo<br>* Parallel Assignment<br>|
| Experimental: AT-752 500 mg single dose<br>AT-752 administered orally, 500 mg single doses on Day 1 and Day 7 | Drug: AT-752<br>* Parallel Assignment<br>|
| Placebo Comparator: Placebo- single dose<br>Matching placebo administered orally on Day 1 and Day 7 | Drug: Placebo<br>* Parallel Assignment<br>|
| Experimental: AT-752 1000 mg single dose<br>AT-752 administered orally, 1000 mg single dose on Day 1 | Drug: AT-752<br>* Parallel Assignment<br>|
| Placebo Comparator: Placebo - single dose<br>Matching placebo administered orally on Day 1 | Drug: Placebo<br>* Parallel Assignment<br>|
| Experimental: AT-752 1500 mg single dose<br>AT-752 administered orally, 1500 mg single dose on Day 1 | Drug: AT-752<br>* Parallel Assignment<br>|
| Placebo Comparator: Placebo: single dose<br>Matching placebo administered orally on Day 1 | Drug: Placebo<br>* Parallel Assignment<br>|
| Experimental: AT-752 - 1000 mg QD multiple doses<br>AT-752 - administered orally, 1000 mg once daily (QD) for 7 days | Drug: AT-752<br>* Parallel Assignment<br>|
| Placebo Comparator: Placebo - Administered once daily (QD)<br>Matching placebo administered orally once daily (QD) for 7 days | Drug: Placebo<br>* Parallel Assignment<br>|
| Experimental: AT-752 - 750 mg twice daily (BID)<br>AT-752 administered orally, 750 mg twice daily (BID) for 4 days plus one dose on Day 5. | Drug: AT-752<br>* Parallel Assignment<br>|
| Placebo Comparator: Placebo - Administered twice daily (BID)<br>Matching placebo administered orally twice daily (BID) for 4 days plus one dose on Day 5. | Drug: Placebo<br>* Parallel Assignment<br>|
| Experimental: AT-752 - 750 mg three times daily (TID)<br>AT-752 administered orally, 750 mg three times daily (TID) for 4 days plus one dose on Day 5. | Drug: AT-752<br>* Parallel Assignment<br>|
| Placebo Comparator: Placebo - Administered TID<br>Matching placebo administered orally (TID) for 4 days plus one dose on Day 5. | Drug: Placebo<br>* Parallel Assignment<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 6 for single dose or Day 12 for multiple dose | 
| Pharmacokinetics (PK) of AT-752 of single and multiple ascending oral doses | Maximum plasma concentration (Cmax) | Day 1 for subjects receiving a single fasted dose; Days 1 and 7 for subjects receiving multiple doses | 
| Pharmacokinetics (PK) of AT-752 of single and multiple ascending oral doses | Area under the concentration-time curve (AUC) | Day 1 for subjects receiving a single fasted dose; Days 1 and 7 for subjects receiving multiple doses ] | 
| Effect of food on Pharmacokinetics (PK) of AT-752 of a single oral dose | Maximum plasma concentration (Cmax) | Day 1 for subjects receiving a single fed dose] | 
| Effect of food on Pharmacokinetics (PK) of AT-752 of a single oral dose | Area under the concentration-time curve (AUC) | Day 1 for subjects receiving a single fed dose ] |