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AG-946 · 1 trial · 2 indications
| Arm | Type | Description |
|---|---|---|
| Part 1: Single Ascending Dose (SAD) Phase | EXPERIMENTAL | Participants will receive a range of doses of AG-946 or placebo, orally, once on Day 1. AG-946 will be given under fasted or fed conditions. |
| Part 2: Multiple Ascending Dose (MAD) Phase | EXPERIMENTAL | Participants will receive a range of doses of AG-946 or placebo, orally, once daily (QD) for 14 days or using an alternative dosing regimen for up to 28 days under fasted conditions. |
| Part 3: Sickle Cell Disease (SCD) Phase | EXPERIMENTAL | Participants will receive a range of selected ascending doses of AG-946, orally, QD or using an alternative dosing regimen for 28 days. |
| Name | Type | Description |
|---|---|---|
| AG-946 | DRUG | AG-946, oral encapsulated coated-granules or tablets. |
| AG-946 Matched Placebo | DRUG | AG-946 matched-placebo, oral encapsulated sugar spheres or tablets. |
Inclusion Criteria: SAD and MAD * Participant is a healthy male or a female of nonchildbearing potential aged 18 to 55 years inclusive at the time of consent; * Participant is able to understand and provide informed consent before the conduct of any protocol-specific screening procedures; * Partic...
AG-946 is an investigational small molecule being studied in hematology. It is being evaluated in healthy volunteers and in participants with sickle cell disease and anemia. The drug is currently in Phase 1 clinical development and is not approved for any use.
AG-946 is being developed by Agios Pharmaceuticals, Inc., a biopharmaceutical company traded on NASDAQ under the ticker AGIO. The company is conducting clinical research on this investigational small molecule in the field of hematology.
AG-946 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 1 study has been completed, and the drug remains under investigation for potential therapeutic use.
AG-946 has one completed Phase 1 clinical trial, identified as NCT04536792. This study assessed the safety, tolerability, pharmacokinetics, and pharmacodynamics of AG-946 in healthy volunteers and in participants with sickle cell disease. The trial enrolled 122 participants across the United States, Denmark, and Spain.
AG-946 is the investigational name for this drug candidate. No alternative names have been reported for AG-946 in the available clinical trial information. It is a distinct small molecule being developed by Agios Pharmaceuticals.