Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AZD3974 · 1 trial · 1 indication
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...
AZD3974 is an investigational small molecule being studied in healthy participants. It is currently in Phase 1 clinical development, with a single active trial evaluating its safety, tolerability, and pharmacokinetics. The drug is not approved for any indication and remains in early-stage clinical testing.
AZD3974 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker AZN. The company is conducting a Phase 1 study of this investigational small molecule in healthy participants.
AZD3974 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The ongoing Phase 1 trial is recruiting participants to assess the drug's safety, tolerability, and pharmacokinetics in healthy volunteers.
AZD3974 is being studied in one active clinical trial, identified as NCT07290283. This Phase 1 study is titled 'A Study to Investigate Safety, Tolerability, and Pharmacokinetics of AZD3974 in Healthy Participants' and is currently recruiting in the United States with an enrollment target of 176 participants.
AZD3974 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The ongoing trial is designed to evaluate the safety, tolerability, and pharmacokinetics of the drug in healthy participants, and it has not yet progressed to later-stage studies or regulatory review.