NCT07728487

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P75+ for phase_1

Timeline
2mo left

Started Jul 2026

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress59%
Jul 2026Dec 2026

Study Start

First participant enrolled

July 13, 2026

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

July 22, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 27, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

July 27, 2026

Status Verified

July 1, 2026

Enrollment Period

5 months

First QC Date

July 22, 2026

Last Update Submit

July 22, 2026

Conditions

Hepatitis E

Outcome Measures

Primary Outcomes (1)

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

    Day 1 up to Day 13

Secondary Outcomes (2)

  • Pharmacokinetics (PK) of AT-587 (Cmax)

    Day 1 up to Day 13

  • Pharmacokinetics (PK) of AT-587 (AUC)

    Day 1 up to Day 13

Study Arms (14)

AT-587 Dose 1 (Day 1)

EXPERIMENTAL

AT-587 administered orally, dose 1 on Day 1

Drug: AT-587

Placebo -Dose 1 (Day 1)

PLACEBO COMPARATOR

Matching placebo dose 1 administered orally on Day 1

Other: Placebo

AT-587 Dose 2 (Day 1 and Day 7)

EXPERIMENTAL

AT-587 administrated orally, dose 2 on Day 1 and Day 7

Drug: AT-587

Placebo-Dose 2 (Day 1 and Day 7)

PLACEBO COMPARATOR

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

Other: Placebo

AT-587 Dose 3 - (Day 1)

EXPERIMENTAL

AT-587 administered orally, dose 3 on Day 1

Drug: AT-587

Placebo - Dose 3 - (Day 1)

PLACEBO COMPARATOR

Matching placebo dose 3 administered orally on Day 1

Other: Placebo

AT-587 Dose 4 - (Day 1)

EXPERIMENTAL

AT-587 administered orally, dose 4 on Day 1

Drug: AT-587

Placebo - Dose 4- (Day 1)

PLACEBO COMPARATOR

Matching placebo dose 4 administered orally on Day 1

Other: Placebo

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

EXPERIMENTAL

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

Drug: AT-587

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

PLACEBO COMPARATOR

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

Other: Placebo

AT-587 - Dose 6 split (BID) (Day 1-7)

EXPERIMENTAL

AT-587 administered orally, dose 6 daily split (BID) for 7 days

Drug: AT-587

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

PLACEBO COMPARATOR

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

Other: Placebo

AT-587 - Dose 7 (QD) or split (BID) daily (Day 1-7)

EXPERIMENTAL

AT-587 administered orally, dose 7 (QD) or split (BID) for 7 days

Drug: AT-587

Placebo - Dose 7 (QD) or split (BID) (Day 1-7)

PLACEBO COMPARATOR

Matching placebo administered orally, dose 7 daily (QD) or split (BID) for 7 days

Other: Placebo

Interventions

AT-587DRUG

Parallel Assignment

AT-587 - Dose 5 (Day 1-7)AT-587 - Dose 6 split (BID) (Day 1-7)AT-587 - Dose 7 (QD) or split (BID) daily (Day 1-7)AT-587 Dose 1 (Day 1)AT-587 Dose 2 (Day 1 and Day 7)AT-587 Dose 3 - (Day 1)AT-587 Dose 4 - (Day 1)
PlaceboOTHER

Parallel Assignment

Placebo - Dose 3 - (Day 1)Placebo - Dose 4- (Day 1)Placebo - Dose 6 (BID) (Day 1-7)Placebo - Dose 7 (QD) or split (BID) (Day 1-7)Placebo -Dose 1 (Day 1)Placebo- Dose 5 (QD) (Day 1-7)Placebo-Dose 2 (Day 1 and Day 7)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Pregnant or breastfeeding
  • Abuse of alcohol or drugs
  • Use of other investigational drugs within 30 days of dosing
  • Other clinically significant medical conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atea Study Site

Edegem, 2650, Belgium

RECRUITING

MeSH Terms

Conditions

Hepatitis E

Condition Hierarchy (Ancestors)

Hepatitis, Viral, HumanVirus DiseasesInfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Central Study Contacts

Clinical Trials Administrator

CONTACT

888-481-1607AteaClinicalTrials@ateapharma.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2026

First Posted

July 27, 2026

Study Start

July 13, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

July 27, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)