Study of AT-752 in Healthy Subjects

Sponsor

Atea Pharmaceuticals, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04722627

Collaborator

(none)

Enrollment

Location

Arms

6.8

Anticipated Duration (Months)

7.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Dengue	Drug: AT-752 Drug: Placebo	Phase 1

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 Design

Study Type:

Interventional

Anticipated Enrollment :

48 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Mar 9, 2021

Anticipated Primary Completion Date :

Oct 1, 2021

Anticipated Study Completion Date :

Oct 1, 2021

Arms and Interventions

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 - 500 mg twice daily (BID) AT-752 administered orally, 500 mg twice daily (BID) for 7 days.	Drug: AT-752 Parallel Assignment
Placebo Comparator: Placebo - Administered twice daily (BID) Matching placebo administered orally twice daily (BID) for 7 days.	Drug: Placebo Parallel Assignment

Outcome Measures

Primary Outcome Measures

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 [Day 1 for subjects receiving a single fasted dose; Days 1 and 7 for subjects receiving multiple doses]
Maximum plasma concentration (Cmax)
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]]
Maximum plasma concentration (Cmax)
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Atea Study Site	Melbourne	Victoria	Australia	3004

Sponsors and Collaborators

Atea Pharmaceuticals, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Atea Pharmaceuticals, Inc.

ClinicalTrials.gov Identifier:

NCT04722627

Other Study ID Numbers:

AT-02A-001

First Posted:

Jan 25, 2021

Last Update Posted:

Jul 29, 2021

Last Verified:

Jul 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Dengue

Study Results

No Results Posted as of Jul 29, 2021