Hepatitis EPhase 1NCT07728487
Study of AT-587 in Healthy Subjects
A Phase 1 study testing AT-587 in people with Hepatitis E, run by Atea Pharmaceuticals, Inc. at 1 site in Belgium.
Trial summary
This study will assess the safety, tolerability and pharmacokinetics (PK) of AT-587 in healthy subjects Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis E
- What is being tested?
- AT-587
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteBelgium
- Study dates
- 13 Jul 2026to Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pregnant or breastfeeding
- Abuse of alcohol or drugs
- Use of other investigational drugs within 30 days of dosing
- Other clinically significant medical conditions
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Atea Study Site
Edegem, 2650
Atea Study Site
About this study
Official title: 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
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
- Conditions
- Hepatitis E
- Being tested
- AT-587, Placebo
- Medical subject headings
- Hepatitis E
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AT-587Drug
Parallel Assignment
PlaceboOther
Parallel Assignment
| Study group | Role | What they receive |
|---|---|---|
| AT-587 Dose 1 (Day 1) | Experimental | AT-587 administered orally, dose 1 on Day 1 Receives: Drug: AT-587 |
| Placebo -Dose 1 (Day 1) | Placebo comparator | Matching placebo dose 1 administered orally on Day 1 Receives: Other: Placebo |
| AT-587 Dose 2 (Day 1 and Day 7) | Experimental | AT-587 administrated orally, dose 2 on Day 1 and Day 7 Receives: 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 Receives: Other: Placebo |
| AT-587 Dose 3 - (Day 1) | Experimental | AT-587 administered orally, dose 3 on Day 1 Receives: Drug: AT-587 |
| Placebo - Dose 3 - (Day 1) | Placebo comparator | Matching placebo dose 3 administered orally on Day 1 Receives: Other: Placebo |
| AT-587 Dose 4 - (Day 1) | Experimental | AT-587 administered orally, dose 4 on Day 1 Receives: Drug: AT-587 |
| Placebo - Dose 4- (Day 1) | Placebo comparator | Matching placebo dose 4 administered orally on Day 1 Receives: Other: Placebo |
| AT-587 - Dose 5 (Day 1-7) | Experimental | AT-587 - administered orally, dose 5 (QD) for 7 days Receives: Drug: AT-587 |
| Placebo- Dose 5 (QD) (Day 1-7) | Placebo comparator | Matching placebo dose 5 administered orally once daily (QD) for 7 days Receives: Other: Placebo |
| AT-587 - Dose 6 split (BID) (Day 1-7) | Experimental | AT-587 administered orally, dose 6 daily split (BID) for 7 days Receives: Drug: AT-587 |
| Placebo - Dose 6 (BID) (Day 1-7) | Placebo comparator | Matching placebo administered orally dose 6 daily split (BID) for 7 days Receives: 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 Receives: 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 Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportions (active vs. Placebo) of subjects experiencing treatment-emergent adverse events
Measured: Day 1 up to Day 13
Secondary outcomes (2)
Pharmacokinetics (PK) of AT-587 (Cmax)
Maximum plasma concentration (Cmax)
Measured: Day 1 up to Day 13
Pharmacokinetics (PK) of AT-587 (AUC)
Area under the concentration-time curve (AUC)
Measured: Day 1 up to Day 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2026
- Study start13 Jul 2026
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis EStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Atea Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07728487
- Sponsor's protocol ID
- AT-05E-001
- Status last verified
- Jul 2026
- First submitted
- 22 Jul 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07728487
- Acronym / sponsor ID
- AT-05E-001
- Conditions
- Hepatitis E
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Atea Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Jul 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 27 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 14
| Arm | Type | Receives |
|---|---|---|
| AT-587 Dose 1 (Day 1) | Experimental | Drug: AT-587AT-587 administered orally, dose 1 on Day 1 |
| Placebo -Dose 1 (Day 1) | Placebo comparator | Other: PlaceboMatching placebo dose 1 administered orally on Day 1 |
| AT-587 Dose 2 (Day 1 and Day 7) | Experimental | Drug: AT-587AT-587 administrated orally, dose 2 on Day 1 and Day 7 |
| Placebo-Dose 2 (Day 1 and Day 7) | Placebo comparator | Other: PlaceboMatching placebo dose 2 administered orally on Day 1 and Day 7 |
| AT-587 Dose 3 - (Day 1) | Experimental | Drug: AT-587AT-587 administered orally, dose 3 on Day 1 |
| Placebo - Dose 3 - (Day 1) | Placebo comparator | Other: PlaceboMatching placebo dose 3 administered orally on Day 1 |
| AT-587 Dose 4 - (Day 1) | Experimental | Drug: AT-587AT-587 administered orally, dose 4 on Day 1 |
| Placebo - Dose 4- (Day 1) | Placebo comparator | Other: PlaceboMatching placebo dose 4 administered orally on Day 1 |
| AT-587 - Dose 5 (Day 1-7) | Experimental | Drug: AT-587AT-587 - administered orally, dose 5 (QD) for 7 days |
| Placebo- Dose 5 (QD) (Day 1-7) | Placebo comparator | Other: PlaceboMatching placebo dose 5 administered orally once daily (QD) for 7 days |
| AT-587 - Dose 6 split (BID) (Day 1-7) | Experimental | Drug: AT-587AT-587 administered orally, dose 6 daily split (BID) for 7 days |
| Placebo - Dose 6 (BID) (Day 1-7) | Placebo comparator | Other: PlaceboMatching placebo administered orally dose 6 daily split (BID) for 7 days |
| AT-587 - Dose 7 (QD) or split (BID) daily (Day 1-7) | Experimental | Drug: AT-587AT-587 administered orally, dose 7 (QD) or split (BID) for 7 days |
| Placebo - Dose 7 (QD) or split (BID) (Day 1-7) | Placebo comparator | Other: PlaceboMatching placebo administered orally, dose 7 daily (QD) or split (BID) for 7 days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Pregnant or breastfeeding
- Abuse of alcohol or drugs
- Use of other investigational drugs within 30 days of dosing
- Other clinically significant medical conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AT-587Parallel Assignment | Drug | 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) |
| PlaceboParallel Assignment | Other | 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) |
Primary outcome
Proportions (active vs. Placebo) of subjects experiencing treatment-emergent adverse events
Time frame: Day 1 up to Day 13
2 secondary outcomes
Pharmacokinetics (PK) of AT-587 (Cmax)
Time frame: Day 1 up to Day 13
Pharmacokinetics (PK) of AT-587 (AUC)
Time frame: Day 1 up to Day 13
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AT-587 in people with Hepatitis E, run by Atea Pharmaceuticals, Inc. at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Administrator (888-481-1607, AteaClinicalTrials@ateapharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportions (active vs. Placebo) of subjects experiencing treatment-emergent adverse events (time frame: Day 1 up to Day 13). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.