ClinicalTrials.gg
RecruitingNCT07728487Updated Jul 27, 2026

Study of AT-587 in Healthy Subjects

A Phase 1 interventional study of AT-587 and Placebo in Hepatitis E, sponsored by Atea Pharmaceuticals, Inc.. Recruiting at 1 site in Belgium. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-27.

Sponsored by Atea Pharmaceuticals, Inc. · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started Jul 2026; still recruiting 3 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
62
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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

Read the 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

02

Conditions studied

  • Hepatitis E

Browse trials for

03

In context

Hepatitis E

37 studies on the registry are indexed under Hepatitis E; 9 are open to participants now.

This study's planned enrollment of 62 is below the median of 330 across 26 interventional studies indexed under Hepatitis E.

Browse Hepatitis E studies →

Lead sponsor

Atea Pharmaceuticals, Inc. is the lead sponsor of 33 studies on the registry; 1 is open to participants now.

Of its 25 completed or terminated interventional studies of FDA-regulated products, 4 (16%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • (BMI) of 18-29 kg/m2
  • Must agree to use protocol-specified methods of
  • Negative pregnancy test
  • Willing to comply with the study requirements and to provide written

Exclusion criteria

Exclusion Criteria:

  • Pregnant or breastfeeding
  • Abuse of alcohol or drugs
  • Use of other drugs within 30 days of dosing
  • Other medical conditions
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
62 participants (estimated)

Study arms

  • Experimental
    AT-587 Dose 1 (Day 1)

    AT-587 administered orally, dose 1 on Day 1

    Drug: AT-587

  • Placebo comparator
    Placebo -Dose 1 (Day 1)

    Matching placebo dose 1 administered orally on Day 1

    Other: Placebo

  • 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

  • Placebo comparator
    Placebo-Dose 2 (Day 1 and Day 7)

    Matching placebo dose 2 administered orally on Day 1 and Day 7

    Other: Placebo

  • Experimental
    AT-587 Dose 3 - (Day 1)

    AT-587 administered orally, dose 3 on Day 1

    Drug: AT-587

  • Placebo comparator
    Placebo - Dose 3 - (Day 1)

    Matching placebo dose 3 administered orally on Day 1

    Other: Placebo

  • Experimental
    AT-587 Dose 4 - (Day 1)

    AT-587 administered orally, dose 4 on Day 1

    Drug: AT-587

  • Placebo comparator
    Placebo - Dose 4- (Day 1)

    Matching placebo dose 4 administered orally on Day 1

    Other: Placebo

  • Experimental
    AT-587 - Dose 5 (Day 1-7)

    AT-587 - administered orally, dose 5 (QD) for 7 days

    Drug: AT-587

  • Placebo comparator
    Placebo- Dose 5 (QD) (Day 1-7)

    Matching placebo dose 5 administered orally once daily (QD) for 7 days

    Other: Placebo

  • 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

  • Placebo comparator
    Placebo - Dose 6 (BID) (Day 1-7)

    Matching placebo administered orally dose 6 daily split (BID) for 7 days

    Other: Placebo

  • 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

  • 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

Interventions

  • DrugAT-587

    Parallel Assignment

  • OtherPlacebo

    Parallel Assignment

06

What researchers measure

Primary outcomes

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

    Time frame: Day 1 up to Day 13

Secondary outcomes

  1. Pharmacokinetics (PK) of AT-587 (Cmax)

    Maximum plasma concentration (Cmax)

    Time frame: Day 1 up to Day 13

  2. Pharmacokinetics (PK) of AT-587 (AUC)

    Area under the concentration-time curve (AUC)

    Time frame: Day 1 up to Day 13

07

Study locations

1 of 1 sites recruiting
  • Atea Study Site
    Edegem, 2650, Belgium
    Recruiting
    • Atea Study Site · Contact
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07728487
Responsible party
Sponsor
First posted
Jul 27, 2026
Start date
Jul 13, 2026
Primary completion
Dec 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Jul 27, 2026

Study contacts

Clinical Trials Administrator
Contact
AteaClinicalTrials@ateapharma.com
888-481-1607

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion