Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05256732 | Study of AT-527 in Healthy Subjects Under Fasting Conditions or With a Meal | PHASE1 | COMPLETED | 136 | — | — | Feb 22, 2022 | Aug 23, 2022 | Oct 18, 2022 | 1 | Canada |
Maximum plasma concentration (Cmax)
| Arm | Type | Description |
|---|---|---|
| AT-527 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| AT-527 BID | EXPERIMENTAL | - |
| AT-527 single dose fasted/fed | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| AT-527 fasted | DRUG | AT-527 administered twice daily (BID) for 5 days fasted |
| Placebo Comparator fasted | OTHER | Matching placebo administered twice daily (BID) for 5 days fasted |
| AT-527 fed | DRUG | AT-527 administered twice daily (BID) for 5 days fed |
| Placebo Comparator fed | OTHER | Matching placebo administered twice daily (BID) for 5 days fed |
| AT-527 | DRUG | AT-527 administered twice daily (BID) |
| AT-527 single dose | DRUG | AT-527 single dose fasted/fed cross-over |
Inclusion Criteria: * Must agree to use two methods of birth control from Screening through 90 days after administration of the last dose of study drug * Females must have a negative pregnancy test at Screening and prior to dosing * Minimum body weight of 50 kg and body mass index (BMI) of 18-32 kg...