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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07290283 | A Study to Investigate Safety, Tolerability, and Pharmacokinetics of AZD3974 in Healthy Participants | PHASE1 | RECRUITING | 176 | — | — | Dec 10, 2025 | Oct 21, 2026 | May 28, 2026 | 2 | United States |
To assess the safety and tolerability of AZD3974 following oral administration of single and multiple ascending doses in healthy participants, including Chinese and Japanese participants
| Arm | Type | Description |
|---|---|---|
| Part A1 (SAD) Cohort 1: AZD3974 (Dose 1) | EXPERIMENTAL | Healthy participants will receive a single dose of AZD3974 - Dose 1 |
| Part A1 (SAD) Cohort 2: AZD3974 (Dose 2) | EXPERIMENTAL | Healthy participants will receive a single dose of AZD3974 - Dose 2 |
| Part A1 (SAD) Cohort 3: AZD3974 (Dose 3) (Food Effect Cohort) | EXPERIMENTAL | Healthy participants will receive two single doses of AZD3974 - Dose 3 |
| Part A1 (SAD) Cohort 4: AZD3974 (Dose 4) | EXPERIMENTAL | Healthy participants will receive a single dose of AZD3974 - Dose 4 |
| Part A1 (SAD) Cohort 5: AZD3974 (Dose 5) | EXPERIMENTAL | Healthy participants will receive a single dose of AZD3974 - Dose 5 |
| Part A1 (SAD) Cohort 6: AZD3974 (Dose 6) | EXPERIMENTAL | Healthy participants will receive a single dose of AZD3974 - Dose 6 |
| Part A1 (SAD) optional additional Cohort 7: AZD3974 | EXPERIMENTAL | Healthy participants will receive a single dose of AZD3974 |
| Part A1 (SAD) optional additional Cohort 8: AZD3974 | EXPERIMENTAL | Healthy participants will receive a single dose of AZD3974 |
| Part A1 (SAD) Cohort: Placebo | PLACEBO_COMPARATOR | Healthy participants will receive a single dose of matching placebo to AZD3974 |
| Part A1 (SAD) Cohort 3: Placebo (Food Effect Cohort) | PLACEBO_COMPARATOR | Healthy participants will receive two single doses of matching placebo to AZD3974 |
| Part A2 (SAD) Japanese Cohort 1: AZD3974 | EXPERIMENTAL | Healthy Japanese participants will receive a single dose of AZD3974 |
| Part A2 (SAD) Japanese Cohort 2: AZD3974 | EXPERIMENTAL | Healthy Japanese participants will receive a single dose of AZD3974 |
| Part A2 (SAD) Japanese Cohort 3: AZD3974 | EXPERIMENTAL | Healthy Japanese participants will receive a single dose of AZD3974 |
| Part A2 (SAD) optional additional Japanese Cohort 4: AZD3974 | EXPERIMENTAL | Healthy Japanese participants will receive a single dose of AZD3974 |
| Part A2 (SAD) Japanese Cohort: Placebo | PLACEBO_COMPARATOR | Healthy Japanese participants will receive a single dose of matching placebo to AZD3974 |
| Part A3 (SAD) Chinese Cohort 1: AZD3974 | EXPERIMENTAL | Healthy Chinese participants will receive a single dose of AZD3974 |
| Part A3 (SAD) optional additional Chinese Cohort 2: AZD3974 | EXPERIMENTAL | Healthy Chinese participants will receive a single dose of AZD3974 |
| Part A3 (SAD) Chinese Cohort: Placebo | PLACEBO_COMPARATOR | Healthy Chinese participants will receive a single dose of matching placebo to AZD3974 |
| Part B1 (MAD) Cohort 1: AZD3974 | EXPERIMENTAL | Healthy participants will receive multiple doses of AZD3974 |
| Part B1 (MAD) Cohort 2: AZD3974 | EXPERIMENTAL | Healthy participants will receive multiple doses of AZD3974 |
| Part B1 (MAD) Cohort 3: AZD3974 | EXPERIMENTAL | Healthy participants will receive multiple doses of AZD3974 |
| Part B1 (MAD) Cohort 4: AZD3974 | EXPERIMENTAL | Healthy participants will receive multiple doses of AZD3974 |
| Part B1 (MAD) optional additional Cohort 5: AZD3974 | EXPERIMENTAL | Healthy participants will receive multiple doses of AZD3974 |
| Part B1 (MAD) optional additional Cohort 6: AZD3974 | EXPERIMENTAL | Healthy participants will receive multiple doses of AZD3974 |
| Part Bl (MAD) Cohort: Placebo | PLACEBO_COMPARATOR | Healthy participants will receive multiple doses of matching placebo to AZD3974 |
| Part B2 (MAD) Japanese Cohort 1: AZD3974 | EXPERIMENTAL | Healthy Japanese participants will receive multiple doses of AZD397 |
| Part B2 (MAD) optional additional Japanese Cohort 2: AZD3974 | EXPERIMENTAL | Healthy Japanese participants will receive multiple doses of matching placebo to AZD3974 |
| Part B2 (MAD) Japanese Cohort: Placebo | PLACEBO_COMPARATOR | Healthy Japanese participants will receive multiple doses of matching placebo to AZD3974 |
| Name | Type | Description |
|---|---|---|
| AZD3974 | DRUG | AZD3974 will be administered as an oral solution. |
| Placebo | OTHER | Placebo will be administered as an oral solution. |
Inclusion Criteria: * Healthy male and female (of non-childbearing potential) participants with suitable veins for cannulation or repeated venipuncture at the Screening Visit. * All females must have a negative pregnancy test. Females of non-childbearing potential must be confirmed via post-menopau...