Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will assess the safety, tolerability and pharmacokinetics (PK) of AT-752 in healthy subjects
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AT-752 250 mg single dose | Experimental | AT-752 administered orally, 250 mg on Day 1 |
|
| Placebo -single dose | Placebo Comparator | Matching placebo administered orally on Day 1 |
|
| AT-752 500 mg single dose | Experimental | AT-752 administered orally, 500 mg single doses on Day 1 and Day 7 |
|
| Placebo- single dose | Placebo Comparator | Matching placebo administered orally on Day 1 and Day 7 |
|
| AT-752 1000 mg single dose | Experimental | AT-752 administered orally, 1000 mg single dose on Day 1 |
|
| Placebo - single dose | Placebo Comparator | Matching placebo administered orally on Day 1 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AT-752 | Drug | Parallel Assignment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportions (active vs. Placebo) of subjects experiencing treatment-emergent adverse events | 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) | 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) | 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) | 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) | Day 1 for subjects receiving a single fed dose ] |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atea Study Site | Melbourne | Victoria | 3004 | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42253092 | Derived | 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. | |
| 38526047 | Derived | Zhou 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003715 | Dengue |
| ID | Term |
|---|---|
| D000096724 | Mosquito-Borne Diseases |
| D000079426 | Vector Borne Diseases |
| D007239 | Infections |
| D001102 | Arbovirus Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| C000728630 | AT-752 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| AT-752 1500 mg single dose | Experimental | AT-752 administered orally, 1500 mg single dose on Day 1 |
|
| Placebo: single dose | Placebo Comparator | Matching placebo administered orally on Day 1 |
|
| AT-752 - 1000 mg QD multiple doses | Experimental | AT-752 - administered orally, 1000 mg once daily (QD) for 7 days |
|
| Placebo - Administered once daily (QD) | Placebo Comparator | Matching placebo administered orally once daily (QD) for 7 days |
|
| 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. |
|
| Placebo - Administered twice daily (BID) | Placebo Comparator | Matching placebo administered orally twice daily (BID) for 4 days plus one dose on Day 5. |
|
| 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. |
|
| Placebo - Administered TID | Placebo Comparator | Matching placebo administered orally (TID) for 4 days plus one dose on Day 5. |
|
| Placebo | Drug | Parallel Assignment |
|
| D014777 |
| Virus Diseases |
| D018177 | Flavivirus Infections |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006482 | Hemorrhagic Fevers, Viral |