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Study of AT-587 in Healthy Subjects

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

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07728487
Enrollment
62
Registered
2026-07-27
Start date
2026-07-13
Completion date
2026-12-01
Last updated
2026-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis E

Brief summary

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

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

Interventions

DRUGAT-587

Parallel Assignment

OTHERPlacebo

Parallel Assignment

Sponsors

Atea Pharmaceuticals, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
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

Design outcomes

Primary

MeasureTime frame
Proportions (active vs. Placebo) of subjects experiencing treatment-emergent adverse eventsDay 1 up to Day 13

Secondary

MeasureTime frameDescription
Pharmacokinetics (PK) of AT-587 (Cmax)Day 1 up to Day 13Maximum plasma concentration (Cmax)
Pharmacokinetics (PK) of AT-587 (AUC)Day 1 up to Day 13Area under the concentration-time curve (AUC)

Countries

Belgium

Contacts

CONTACTClinical Trials Administrator
AteaClinicalTrials@ateapharma.com888-481-1607

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 28, 2026