Study of AT-587 in Healthy Subjects

July 22, 2026 updated by: Atea Pharmaceuticals, Inc.

A Phase 1, First-in-Human (FIH), Single-center, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics (PK) of AT-587 in Healthy Adult Participants

This study will assess the safety, tolerability and pharmacokinetics (PK) of AT-587 in healthy subjects

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

A Phase 1, First-in-Human (FIH), Single-center, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics (PK) of AT-587 in Healthy Adult Participants

Study Type

Interventional

Enrollment (Estimated)

62

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Belgium
      • Edegem, Belgium, 2650
        • Recruiting
        • Atea Study Site
        • Contact:
          • Atea Study Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AT-587 Dose 1 (Day 1)
AT-587 administered orally, dose 1 on Day 1
Drug: AT-587
Parallel Assignment
Placebo Comparator: Placebo -Dose 1 (Day 1)
Matching placebo dose 1 administered orally on Day 1
Other: Placebo
Parallel Assignment
Experimental: AT-587 Dose 2 (Day 1 and Day 7)
AT-587 administrated orally, dose 2 on Day 1 and Day 7
Drug: AT-587
Parallel Assignment
Placebo Comparator: Placebo-Dose 2 (Day 1 and Day 7)
Matching placebo dose 2 administered orally on Day 1 and Day 7
Other: Placebo
Parallel Assignment
Experimental: AT-587 Dose 3 - (Day 1)
AT-587 administered orally, dose 3 on Day 1
Drug: AT-587
Parallel Assignment
Placebo Comparator: Placebo - Dose 3 - (Day 1)
Matching placebo dose 3 administered orally on Day 1
Other: Placebo
Parallel Assignment
Experimental: AT-587 Dose 4 - (Day 1)
AT-587 administered orally, dose 4 on Day 1
Drug: AT-587
Parallel Assignment
Placebo Comparator: Placebo - Dose 4- (Day 1)
Matching placebo dose 4 administered orally on Day 1
Other: Placebo
Parallel Assignment
Experimental: AT-587 - Dose 5 (Day 1-7)
AT-587 - administered orally, dose 5 (QD) for 7 days
Drug: AT-587
Parallel Assignment
Placebo Comparator: Placebo- Dose 5 (QD) (Day 1-7)
Matching placebo dose 5 administered orally once daily (QD) for 7 days
Other: Placebo
Parallel Assignment
Experimental: AT-587 - Dose 6 split (BID) (Day 1-7)
AT-587 administered orally, dose 6 daily split (BID) for 7 days
Drug: AT-587
Parallel Assignment
Placebo Comparator: Placebo - Dose 6 (BID) (Day 1-7)
Matching placebo administered orally dose 6 daily split (BID) for 7 days
Other: Placebo
Parallel Assignment
Experimental: AT-587 - Dose 7 (QD) or split (BID) daily (Day 1-7)
AT-587 administered orally, dose 7 (QD) or split (BID) for 7 days
Drug: AT-587
Parallel Assignment
Placebo Comparator: Placebo - Dose 7 (QD) or split (BID) (Day 1-7)
Matching placebo administered orally, dose 7 daily (QD) or split (BID) for 7 days
Other: Placebo
Parallel Assignment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportions (active vs. Placebo) of subjects experiencing treatment-emergent adverse events
Time Frame: Day 1 up to Day 13
Day 1 up to Day 13

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetics (PK) of AT-587 (Cmax)
Time Frame: Day 1 up to Day 13
Maximum plasma concentration (Cmax)
Day 1 up to Day 13
Pharmacokinetics (PK) of AT-587 (AUC)
Time Frame: Day 1 up to Day 13
Area under the concentration-time curve (AUC)
Day 1 up to Day 13

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Atea Pharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 13, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

July 22, 2026

First Submitted That Met QC Criteria

July 22, 2026

First Posted (Actual)

July 27, 2026

Study Record Updates

Last Update Posted (Actual)

July 27, 2026

Last Update Submitted That Met QC Criteria

July 22, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AT-05E-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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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