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Study of AT-752 in Healthy Subjects

Primary Purpose

Dengue

Status

Completed

Phase

Phase 1

Locations

Australia

Study Type

Interventional

Intervention

AT-752

Placebo

About this trial

This is an interventional treatment trial for Dengue

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Atea Study Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm 13

Arm 14

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

AT-752 250 mg single dose

Placebo -single dose

AT-752 500 mg single dose

Placebo- single dose

AT-752 1000 mg single dose

Placebo - single dose

AT-752 1500 mg single dose

Placebo: single dose

AT-752 - 1000 mg QD multiple doses

Placebo - Administered once daily (QD)

AT-752 - 750 mg twice daily (BID)

Placebo - Administered twice daily (BID)

AT-752 - 750 mg three times daily (TID)

Placebo - Administered TID

Arm Description

AT-752 administered orally, 250 mg on Day 1

Matching placebo administered orally on Day 1

AT-752 administered orally, 500 mg single doses on Day 1 and Day 7

Matching placebo administered orally on Day 1 and Day 7

AT-752 administered orally, 1000 mg single dose on Day 1

Matching placebo administered orally on Day 1

AT-752 administered orally, 1500 mg single dose on Day 1

Matching placebo administered orally on Day 1

AT-752 - administered orally, 1000 mg once daily (QD) for 7 days

Matching placebo administered orally once daily (QD) for 7 days

AT-752 administered orally, 750 mg twice daily (BID) for 4 days plus one dose on Day 5.

Matching placebo administered orally twice daily (BID) for 4 days plus one dose on Day 5.

AT-752 administered orally, 750 mg three times daily (TID) for 4 days plus one dose on Day 5.

Matching placebo administered orally (TID) for 4 days plus one dose on Day 5.

Outcomes

Primary Outcome Measures

Proportions (active vs. Placebo) of subjects experiencing treatment-emergent adverse events

Pharmacokinetics (PK) of AT-752 of single and multiple ascending oral doses

Maximum plasma concentration (Cmax)

Pharmacokinetics (PK) of AT-752 of single and multiple ascending oral doses

Area under the concentration-time curve (AUC)

Effect of food on Pharmacokinetics (PK) of AT-752 of a single oral dose

Maximum plasma concentration (Cmax)

Effect of food on Pharmacokinetics (PK) of AT-752 of a single oral dose

Area under the concentration-time curve (AUC)

Secondary Outcome Measures

Full Information

NCT ID

NCT04722627

First Posted

January 20, 2021

Last Updated

October 14, 2022

Sponsor

Atea Pharmaceuticals, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04722627

Brief Title

Study of AT-752 in Healthy Subjects

Official Title

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

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Completed

Study Start Date

March 9, 2021 (Actual)

Primary Completion Date

November 14, 2021 (Actual)

Study Completion Date

November 14, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Atea Pharmaceuticals, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dengue

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Sequential Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

65 (Actual)

8. Arms, Groups, and Interventions

Arm Title

AT-752 250 mg single dose

Arm Type

Experimental

Arm Description

AT-752 administered orally, 250 mg on Day 1

Arm Title

Placebo -single dose

Arm Type

Placebo Comparator

Arm Description

Matching placebo administered orally on Day 1

Arm Title

AT-752 500 mg single dose

Arm Type

Experimental

Arm Description

AT-752 administered orally, 500 mg single doses on Day 1 and Day 7

Arm Title

Placebo- single dose

Arm Type

Placebo Comparator

Arm Description

Matching placebo administered orally on Day 1 and Day 7

Arm Title

AT-752 1000 mg single dose

Arm Type

Experimental

Arm Description

AT-752 administered orally, 1000 mg single dose on Day 1

Arm Title

Placebo - single dose

Arm Type

Placebo Comparator

Arm Description

Matching placebo administered orally on Day 1

Arm Title

AT-752 1500 mg single dose

Arm Type

Experimental

Arm Description

AT-752 administered orally, 1500 mg single dose on Day 1

Arm Title

Placebo: single dose

Arm Type

Placebo Comparator

Arm Description

Matching placebo administered orally on Day 1

Arm Title

AT-752 - 1000 mg QD multiple doses

Arm Type

Experimental

Arm Description

AT-752 - administered orally, 1000 mg once daily (QD) for 7 days

Arm Title

Placebo - Administered once daily (QD)

Arm Type

Placebo Comparator

Arm Description

Matching placebo administered orally once daily (QD) for 7 days

Arm Title

AT-752 - 750 mg twice daily (BID)

Arm Type

Experimental

Arm Description

AT-752 administered orally, 750 mg twice daily (BID) for 4 days plus one dose on Day 5.

Arm Title

Placebo - Administered twice daily (BID)

Arm Type

Placebo Comparator

Arm Description

Matching placebo administered orally twice daily (BID) for 4 days plus one dose on Day 5.

Arm Title

AT-752 - 750 mg three times daily (TID)

Arm Type

Experimental

Arm Description

AT-752 administered orally, 750 mg three times daily (TID) for 4 days plus one dose on Day 5.

Arm Title

Placebo - Administered TID

Arm Type

Placebo Comparator

Arm Description

Matching placebo administered orally (TID) for 4 days plus one dose on Day 5.

Intervention Type

Drug

Intervention Name(s)

AT-752

Intervention Description

Parallel Assignment

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Parallel Assignment

Primary Outcome Measure Information:

Title

Proportions (active vs. Placebo) of subjects experiencing treatment-emergent adverse events

Time Frame

Day 6 for single dose or Day 12 for multiple dose

Title

Pharmacokinetics (PK) of AT-752 of single and multiple ascending oral doses

Description

Maximum plasma concentration (Cmax)

Time Frame

Day 1 for subjects receiving a single fasted dose; Days 1 and 7 for subjects receiving multiple doses

Title

Pharmacokinetics (PK) of AT-752 of single and multiple ascending oral doses

Description

Area under the concentration-time curve (AUC)

Time Frame

Day 1 for subjects receiving a single fasted dose; Days 1 and 7 for subjects receiving multiple doses ]

Title

Effect of food on Pharmacokinetics (PK) of AT-752 of a single oral dose

Description

Maximum plasma concentration (Cmax)

Time Frame

Day 1 for subjects receiving a single fed dose]

Title

Effect of food on Pharmacokinetics (PK) of AT-752 of a single oral dose

Description

Area under the concentration-time curve (AUC)

Time Frame

Day 1 for subjects receiving a single fed dose ]

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Atea Study Site

City

Melbourne

State/Province

Victoria

ZIP/Postal Code

3004

Country

Australia

12. IPD Sharing Statement

Plan to Share IPD

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Study of AT-752 in Healthy Subjects

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