DenguePhase 1NCT04722627
Study of AT-752 in Healthy Subjects
A Phase 1 study testing AT-752 in people with Dengue, run by Atea Pharmaceuticals, Inc. at 1 site in Australia.
Trial summary
This study will assess the safety, tolerability and pharmacokinetics (PK) of AT-752 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
- Dengue
- What is being tested?
- AT-752
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 1 siteAustralia
- Study dates
- 9 Mar 2021to 14 Nov 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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.
About this study
Official title: A First-in Human, Randomized, Double-blind, Placebo Controlled Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of AT-752 in Healthy Subjects
This study will assess the safety, tolerability and pharmacokinetics (PK) of AT-752 in healthy subjects
Read the detailed description
A First-in Human, Randomized, Double-blind, Placebo controlled Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of AT-752 in Healthy Subjects
- Conditions
- Dengue
- Being tested
- AT-752, Placebo
- Medical subject headings
- Dengue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AT-752Drug
Parallel Assignment
PlaceboDrug
Parallel Assignment
| Study group | Role | What they receive |
|---|---|---|
| AT-752 250 mg single dose | Experimental | AT-752 administered orally, 250 mg on Day 1 Receives: Drug: AT-752 |
| Placebo -single dose | Placebo comparator | Matching placebo administered orally on Day 1 Receives: Drug: Placebo |
| AT-752 500 mg single dose | Experimental | AT-752 administered orally, 500 mg single doses on Day 1 and Day 7 Receives: Drug: AT-752 |
| Placebo- single dose | Placebo comparator | Matching placebo administered orally on Day 1 and Day 7 Receives: Drug: Placebo |
| AT-752 1000 mg single dose | Experimental | AT-752 administered orally, 1000 mg single dose on Day 1 Receives: Drug: AT-752 |
| Placebo - single dose | Placebo comparator | Matching placebo administered orally on Day 1 Receives: Drug: Placebo |
| AT-752 1500 mg single dose | Experimental | AT-752 administered orally, 1500 mg single dose on Day 1 Receives: Drug: AT-752 |
| Placebo: single dose | Placebo comparator | Matching placebo administered orally on Day 1 Receives: Drug: Placebo |
| AT-752 - 1000 mg QD multiple doses | Experimental | AT-752 - administered orally, 1000 mg once daily (QD) for 7 days Receives: Drug: AT-752 |
| Placebo - Administered once daily (QD) | Placebo comparator | Matching placebo administered orally once daily (QD) for 7 days Receives: Drug: Placebo |
| AT-752 - 750 mg twice daily (BID) | Experimental | AT-752 administered orally, 750 mg twice daily (BID) for 4 days plus one dose on Day 5. Receives: Drug: AT-752 |
| Placebo - Administered twice daily (BID) | Placebo comparator | Matching placebo administered orally twice daily (BID) for 4 days plus one dose on Day 5. Receives: Drug: Placebo |
| AT-752 - 750 mg three times daily (TID) | Experimental | AT-752 administered orally, 750 mg three times daily (TID) for 4 days plus one dose on Day 5. Receives: Drug: AT-752 |
| Placebo - Administered TID | Placebo comparator | Matching placebo administered orally (TID) for 4 days plus one dose on Day 5. Receives: Drug: 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 6 for single dose or Day 12 for multiple dose
Pharmacokinetics (PK) of AT-752 of single and multiple ascending oral doses
Maximum plasma concentration (Cmax)
Measured: Day 1 for subjects receiving a single fasted dose; Days 1 and 7 for subjects receiving multiple doses
Pharmacokinetics (PK) of AT-752 of single and multiple ascending oral doses
Area under the concentration-time curve (AUC)
Measured: Day 1 for subjects receiving a single fasted dose; Days 1 and 7 for subjects receiving multiple doses ]
Effect of food on Pharmacokinetics (PK) of AT-752 of a single oral dose
Maximum plasma concentration (Cmax)
Measured: Day 1 for subjects receiving a single fed dose]
Effect of food on Pharmacokinetics (PK) of AT-752 of a single oral dose
Area under the concentration-time curve (AUC)
Measured: Day 1 for subjects receiving a single fed dose ]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2021
- Study start9 Mar 2021
- Primary completion14 Nov 2021
- Study completion14 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DengueStudies 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
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atea Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04722627
- Sponsor's protocol ID
- AT-02A-001
- Status last verified
- Oct 2022
- First submitted
- 20 Jan 2021
- Last updated
- 17 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bouzidi HS, De Lamballerie X, Touret F. Therapeutic approaches against dengue virus: current status of vaccines, antivirals, and monoclonal antibodies. Emerg Microbes Infect. 2026 Dec;15(1):2686471. doi: 10.1080/22221751.2026.2686471. Epub 2026 Jun 21.
PubMed 42253092Zhou X-J, Lickliter J, Montrond M, Ishak L, Pietropaolo K, James D, Belanger B, Horga A, Hammond J. First-in-human trial evaluating safety and pharmacokinetics of AT-752, a novel nucleotide prodrug with pan-serotype activity against dengue virus. Antimicrob Agents Chemother. 2024 May 2;68(5):e0161523. doi: 10.1128/aac.01615-23. Epub 2024 Mar 25.
PubMed 38526047
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in Human, Randomized, Double-blind, Placebo Controlled Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of AT-752 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04722627
- Acronym / sponsor ID
- AT-02A-001
- Conditions
- Dengue
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Atea Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Mar 2021 (actual)
- Primary completion
- 14 Nov 2021 (actual)
- Study completion
- 14 Nov 2021 (actual)
- First posted
- 25 Jan 2021 (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-752 in healthy subjects
Detailed description
A First-in Human, Randomized, Double-blind, Placebo controlled Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of AT-752 in Healthy Subjects
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-752 250 mg single dose | Experimental | Drug: AT-752AT-752 administered orally, 250 mg on Day 1 |
| Placebo -single dose | Placebo comparator | Drug: PlaceboMatching placebo administered orally on Day 1 |
| AT-752 500 mg single dose | Experimental | Drug: AT-752AT-752 administered orally, 500 mg single doses on Day 1 and Day 7 |
| Placebo- single dose | Placebo comparator | Drug: PlaceboMatching placebo administered orally on Day 1 and Day 7 |
| AT-752 1000 mg single dose | Experimental | Drug: AT-752AT-752 administered orally, 1000 mg single dose on Day 1 |
| Placebo - single dose | Placebo comparator | Drug: PlaceboMatching placebo administered orally on Day 1 |
| AT-752 1500 mg single dose | Experimental | Drug: AT-752AT-752 administered orally, 1500 mg single dose on Day 1 |
| Placebo: single dose | Placebo comparator | Drug: PlaceboMatching placebo administered orally on Day 1 |
| AT-752 - 1000 mg QD multiple doses | Experimental | Drug: AT-752AT-752 - administered orally, 1000 mg once daily (QD) for 7 days |
| Placebo - Administered once daily (QD) | Placebo comparator | Drug: PlaceboMatching placebo administered orally once daily (QD) for 7 days |
| AT-752 - 750 mg twice daily (BID) | Experimental | Drug: AT-752AT-752 administered orally, 750 mg twice daily (BID) for 4 days plus one dose on Day 5. |
| Placebo - Administered twice daily (BID) | Placebo comparator | Drug: PlaceboMatching placebo administered orally twice daily (BID) for 4 days plus one dose on Day 5. |
| AT-752 - 750 mg three times daily (TID) | Experimental | Drug: AT-752AT-752 administered orally, 750 mg three times daily (TID) for 4 days plus one dose on Day 5. |
| Placebo - Administered TID | Placebo comparator | Drug: PlaceboMatching placebo administered orally (TID) for 4 days plus one dose on Day 5. |
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-752Parallel Assignment | Drug | AT-752 - 1000 mg QD multiple doses, AT-752 - 750 mg three times daily (TID), AT-752 - 750 mg twice daily (BID), AT-752 1000 mg single dose, AT-752 1500 mg single dose, AT-752 250 mg single dose, AT-752 500 mg single dose |
| PlaceboParallel Assignment | Drug | Placebo - Administered TID, Placebo - Administered once daily (QD), Placebo - Administered twice daily (BID), Placebo - single dose, Placebo -single dose, Placebo- single dose, Placebo: single dose |
Primary outcome
Proportions (active vs. Placebo) of subjects experiencing treatment-emergent adverse events
Time frame: Day 6 for single dose or Day 12 for multiple dose
Pharmacokinetics (PK) of AT-752 of single and multiple ascending oral doses
Time frame: Day 1 for subjects receiving a single fasted dose; Days 1 and 7 for subjects receiving multiple doses
Maximum plasma concentration (Cmax)
Pharmacokinetics (PK) of AT-752 of single and multiple ascending oral doses
Time frame: Day 1 for subjects receiving a single fasted dose; Days 1 and 7 for subjects receiving multiple doses ]
Area under the concentration-time curve (AUC)
Effect of food on Pharmacokinetics (PK) of AT-752 of a single oral dose
Time frame: Day 1 for subjects receiving a single fed dose]
Maximum plasma concentration (Cmax)
Effect of food on Pharmacokinetics (PK) of AT-752 of a single oral dose
Time frame: Day 1 for subjects receiving a single fed dose ]
Area under the concentration-time curve (AUC)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2022.
- Derived from this study: PubMed 42253092Bouzidi HS, De Lamballerie X, Touret F. Therapeutic approaches against dengue virus: current status of vaccines, antivirals, and monoclonal antibodies. Emerg Microbes Infect. 2026 Dec;15(1):2686471. doi: 10.1080/22221751.2026.2686471. Epub 2026 Jun 21.
- Derived from this study: PubMed 38526047Zhou X-J, Lickliter J, Montrond M, Ishak L, Pietropaolo K, James D, Belanger B, Horga A, Hammond J. First-in-human trial evaluating safety and pharmacokinetics of AT-752, a novel nucleotide prodrug with pan-serotype activity against dengue virus. Antimicrob Agents Chemother. 2024 May 2;68(5):e0161523. doi: 10.1128/aac.01615-23. Epub 2024 Mar 25.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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-752 in people with Dengue, run by Atea Pharmaceuticals, Inc. at 1 site in Australia.
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: finished, as of the sponsor's last update on 17 Oct 2022. 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 Australia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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 6 for single dose or Day 12 for multiple dose). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04722627, which also lists 2 linked publications.
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 17 Oct 2022.