Study of AT-752 in Healthy Subjects

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

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

Study Overview

• Status: Completed
• Conditions: Dengue
• Intervention / Treatment: Drug: AT-752; Drug: Placebo

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 Type: Interventional
• Enrollment (Actual): 65
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Melbourne, Victoria, Australia, 3004
      • Atea Study Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Triple

Number of Arms

14

Arms and Interventions

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

What is the study measuring?

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 ]

Collaborators and Investigators

• Sponsor: Atea Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2021
• Primary Completion (Actual): November 14, 2021
• Study Completion (Actual): November 14, 2021

Study Registration Dates

• First Submitted: January 20, 2021
• First Submitted That Met QC Criteria: January 20, 2021
• First Posted (Actual): January 25, 2021

Study Record Updates

• Last Update Posted (Actual): October 17, 2022
• Last Update Submitted That Met QC Criteria: October 14, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Arbovirus Infections; Vector Borne Diseases; Flavivirus Infections; Flaviviridae Infections; Hemorrhagic Fevers, Viral; Dengue
• Other Study ID Numbers: AT-02A-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No