Study identifier:D7360C00001
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
A Phase I, Randomized, Single-blind, Placebo-controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD3974 After Single and Multiple Ascending Dosing to Healthy Participants
Healthy Participants
Phase 1
Yes
AZD3974
All
176
Interventional
18 Years - 55 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Sequential Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Dec 2025 by AstraZeneca
AstraZeneca
PAREXEL
No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Part A1 (SAD) Cohort 1: AZD3974 (Dose 1) Healthy participants will receive a single dose of AZD3974 - Dose 1 | Drug: AZD3974 AZD3974 will be administered as an oral solution. |
| Experimental: Part A1 (SAD) Cohort 2: AZD3974 (Dose 2) Healthy participants will receive a single dose of AZD3974 - Dose 2 | Drug: AZD3974 AZD3974 will be administered as an oral solution. |
| Experimental: Part A1 (SAD) Cohort 3: AZD3974 (Dose 3) (Food Effect Cohort) Healthy participants will receive two single doses of AZD3974 - Dose 3 | Drug: AZD3974 AZD3974 will be administered as an oral solution. |
| Experimental: Part A1 (SAD) Cohort 4: AZD3974 (Dose 4) Healthy participants will receive a single dose of AZD3974 - Dose 4 | Drug: AZD3974 AZD3974 will be administered as an oral solution. |
| Experimental: Part A1 (SAD) Cohort 5: AZD3974 (Dose 5) Healthy participants will receive a single dose of AZD3974 - Dose 5 | Drug: AZD3974 AZD3974 will be administered as an oral solution. |
| Experimental: Part A1 (SAD) Cohort 6: AZD3974 (Dose 6) Healthy participants will receive a single dose of AZD3974 - Dose 6 | Drug: AZD3974 AZD3974 will be administered as an oral solution. |
| Experimental: Part A1 (SAD) optional additional Cohort 7: AZD3974 Healthy participants will receive a single dose of AZD3974 | Drug: AZD3974 AZD3974 will be administered as an oral solution. |
| Experimental: Part A1 (SAD) optional additional Cohort 8: AZD3974 Healthy participants will receive a single dose of AZD3974 | Drug: AZD3974 AZD3974 will be administered as an oral solution. |
| Placebo Comparator: Part A1 (SAD) Cohort: Placebo Healthy participants will receive a single dose of matching placebo to AZD3974 | Other: Placebo Placebo will be administered as an oral solution. |
| Placebo Comparator: Part A1 (SAD) Cohort 3: Placebo (Food Effect Cohort) Healthy participants will receive two single doses of matching placebo to AZD3974 | Other: Placebo Placebo will be administered as an oral solution. |
| Experimental: Part A2 (SAD) Japanese Cohort 1: AZD3974 Healthy Japanese participants will receive a single dose of AZD3974 | Drug: AZD3974 AZD3974 will be administered as an oral solution. |
| Experimental: Part A2 (SAD) Japanese Cohort 2: AZD3974 Healthy Japanese participants will receive a single dose of AZD3974 | Drug: AZD3974 AZD3974 will be administered as an oral solution. |
| Experimental: Part A2 (SAD) Japanese Cohort 3: AZD3974 Healthy Japanese participants will receive a single dose of AZD3974 | Drug: AZD3974 AZD3974 will be administered as an oral solution. |
| Experimental: Part A2 (SAD) optional additional Japanese Cohort 4: AZD3974 Healthy Japanese participants will receive a single dose of AZD3974 | Drug: AZD3974 AZD3974 will be administered as an oral solution. |
| Placebo Comparator: Part A2 (SAD) Japanese Cohort: Placebo Healthy Japanese participants will receive a single dose of matching placebo to AZD3974 | Other: Placebo Placebo will be administered as an oral solution. |
| Experimental: Part A3 (SAD) Chinese Cohort 1: AZD3974 Healthy Chinese participants will receive a single dose of AZD3974 | Drug: AZD3974 AZD3974 will be administered as an oral solution. |
| Experimental: Part A3 (SAD) optional additional Chinese Cohort 2: AZD3974 Healthy Chinese participants will receive a single dose of AZD3974 | Drug: AZD3974 AZD3974 will be administered as an oral solution. |
| Placebo Comparator: Part A3 (SAD) Chinese Cohort: Placebo Healthy Chinese participants will receive a single dose of matching placebo to AZD3974 | Other: Placebo Placebo will be administered as an oral solution. |
| Experimental: Part B1 (MAD) Cohort 1: AZD3974 Healthy participants will receive multiple doses of AZD3974 | Drug: AZD3974 AZD3974 will be administered as an oral solution. |
| Experimental: Part B1 (MAD) Cohort 2: AZD3974 Healthy participants will receive multiple doses of AZD3974 | Drug: AZD3974 AZD3974 will be administered as an oral solution. |
| Experimental: Part B1 (MAD) Cohort 3: AZD3974 Healthy participants will receive multiple doses of AZD3974 | Drug: AZD3974 AZD3974 will be administered as an oral solution. |
| Experimental: Part B1 (MAD) Cohort 4: AZD3974 Healthy participants will receive multiple doses of AZD3974 | Drug: AZD3974 AZD3974 will be administered as an oral solution. |
| Experimental: Part B1 (MAD) optional additional Cohort 5: AZD3974 Healthy participants will receive multiple doses of AZD3974 | Drug: AZD3974 AZD3974 will be administered as an oral solution. |
| Experimental: Part B1 (MAD) optional additional Cohort 6: AZD3974 Healthy participants will receive multiple doses of AZD3974 | Drug: AZD3974 AZD3974 will be administered as an oral solution. |
| Placebo Comparator: Part Bl (MAD) Cohort: Placebo Healthy participants will receive multiple doses of matching placebo to AZD3974 | Other: Placebo Placebo will be administered as an oral solution. |
| Experimental: Part B2 (MAD) Japanese Cohort 1: AZD3974 Healthy Japanese participants will receive multiple doses of AZD397 | Drug: AZD3974 AZD3974 will be administered as an oral solution. |
| Experimental: Part B2 (MAD) optional additional Japanese Cohort 2: AZD3974 Healthy Japanese participants will receive multiple doses of matching placebo to AZD3974 | Drug: AZD3974 AZD3974 will be administered as an oral solution. |
| Placebo Comparator: Part B2 (MAD) Japanese Cohort: Placebo Healthy Japanese participants will receive multiple doses of matching placebo to AZD3974 | Other: Placebo Placebo will be administered as an oral solution. |