Study of AT-752 in Healthy Subjects

Phase 1

Completed

• Conditions: Dengue
• Interventions: Drug: Placebo; Drug: AT-752

• Registration Number: NCT04722627
• Lead Sponsor: Atea Pharmaceuticals, Inc.

Brief Summary

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

Detailed Description

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

Study Timeline

• Study First Submitted: 2021-01-20
• Study First Submitted QC: 2021-01-20
• Study First Posted: 2021-01-25
• Study Start: 2021-03-09
• Primary Completion: 2021-11-14
• Study Completion: 2021-11-14
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-14
• Last Update Posted: 2022-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

1. Body mass index (BMI) of 18-29 kg/m2
2. Must agree to use protocol-specified methods of contraception
3. Negative pregnancy test
4. Willing to comply with the study requirements and to provide written informed consent

Exclusion Criteria

1. Pregnant or breastfeeding
2. Abuse of alcohol or drugs
3. Use of other investigational drugs within 30 days of dosing
4. Other clinically significant medical conditions

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Placebo -single dose	Placebo	Matching placebo administered orally on Day 1
AT-752 500 mg single dose	AT-752	AT-752 administered orally, 500 mg single doses on Day 1 and Day 7
Placebo- single dose	Placebo	Matching placebo administered orally on Day 1 and Day 7
Placebo - single dose	Placebo	Matching placebo administered orally on Day 1
AT-752 250 mg single dose	AT-752	AT-752 administered orally, 250 mg on Day 1
AT-752 - 1000 mg QD multiple doses	AT-752	AT-752 - administered orally, 1000 mg once daily (QD) for 7 days
Placebo - Administered once daily (QD)	Placebo	Matching placebo administered orally once daily (QD) for 7 days
AT-752 - 750 mg twice daily (BID)	AT-752	AT-752 administered orally, 750 mg twice daily (BID) for 4 days plus one dose on Day 5.
Placebo - Administered twice daily (BID)	Placebo	Matching placebo administered orally twice daily (BID) for 4 days plus one dose on Day 5.
AT-752 - 750 mg three times daily (TID)	AT-752	AT-752 administered orally, 750 mg three times daily (TID) for 4 days plus one dose on Day 5.
Placebo - Administered TID	Placebo	Matching placebo administered orally (TID) for 4 days plus one dose on Day 5.
AT-752 1500 mg single dose	AT-752	AT-752 administered orally, 1500 mg single dose on Day 1
Placebo: single dose	Placebo	Matching placebo administered orally on Day 1
AT-752 1000 mg single dose	AT-752	AT-752 administered orally, 1000 mg single dose on Day 1

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK) of AT-752 of single and multiple ascending oral doses	Day 1 for subjects receiving a single fasted dose; Days 1 and 7 for subjects receiving multiple doses ]	Area under the concentration-time curve (AUC)
Effect of food on Pharmacokinetics (PK) of AT-752 of a single oral dose	Day 1 for subjects receiving a single fed dose ]	Area under the concentration-time curve (AUC)
Proportions (active vs. Placebo) of subjects experiencing treatment-emergent adverse events	Day 6 for single dose or Day 12 for multiple dose

Trial Locations

Locations (1)

Atea Study Site; 🇦🇺 Melbourne, Victoria, Australia