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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04536792 | A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AG-946 in Healthy Volunteers and in Participants With Sickle Cell Disease | PHASE1 | COMPLETED | 122 | — | — | Jul 10, 2020 | Dec 19, 2023 | Apr 16, 2024 | 10 | United States, Denmark +1 |
| 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...