Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AG-348 Sequence A · 1 trial · 1 indication
AG-348 Maximum Plasma Concentration
AG-348 Area Under the Curve
| Arm | Type | Description |
|---|---|---|
| Sequence A | ACTIVE_COMPARATOR | - |
| Sequence B | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| AG-348 Sequence A | DRUG | 1. Treatment Period 1 Single 50 mg dose of AG-348 administered as a capsule formulation (2 × 25 mg capsules) 2. Washout Period 7 days 3. Treatment Period 2 Single 50 mg dose of AG-348 administered as a tablet formulation (1 × 50 mg tablet) |
| AG-348 Sequence B | DRUG | 1. Treatment Period 1 Single 50 mg dose of AG-348 administered as a tablet formulation (1 × 50 mg tablet) 2. Washout Period 7 days 3. Treatment Period 2 Single 50 mg dose of AG-348 administered as a capsule formulation (2 × 25 mg capsules) |
Inclusion Criteria: * Be a male or female aged 18 to 55 years, inclusive. * Have a body mass index (BMI) of ≥ 18.5 to ≤ 29.0 kg/m2 at Screening. * Agrees to abstain from any alcohol consumption. * Be healthy overall with no clinically significant medical abnormalities, as determined by the Investig...
AG-348 Sequence A is an investigational small molecule developed by Agios Pharmaceuticals, Inc. It has been studied in a Phase 1 clinical trial in healthy adult volunteers. The program is in early clinical development, and no approved indication has been established for this sequence.
AG-348 Sequence A is being developed by Agios Pharmaceuticals, Inc., which trades on the Nasdaq under the ticker AGIO. Agios is the sponsor of the clinical work conducted with this sequence.
AG-348 Sequence A is in Phase 1 development. One Phase 1 trial has been completed, and no active trials are currently listed. The program remains investigational and has not been approved by the FDA for any indication.
AG-348 Sequence A was evaluated in NCT03397329, a Phase 1 study titled Study to Evaluate the Relative Bioavailability and Safety of the AG-348 Tablet and Capsule Formulations in Healthy Adults. The trial enrolled 26 healthy adult volunteers in the United States and has been completed.
NCT03397329 was a randomized, active-controlled Phase 1 study comparing AG-348 tablet and capsule formulations in healthy adults aged 18 years and older. It enrolled 26 participants across sites in the United States and was not blinded. The trial has been completed.