Study identifier:D6960C00001
ClinicalTrials.gov identifier:NCT06502379
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 AZD8965 Following Single and Multiple Ascending Dose Administration to Healthy Participants (including Japanese and Chinese Participants) and an Open-label Cohort to Assess the Effect of Food on the Pharmacokinetics of AZD8965 in Healthy Participants
Healthy Participants
Phase 1
Yes
AZD8965
All
163
Interventional
18 Years - 55 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Sequential Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Sept 2024 by AstraZeneca
AstraZeneca
-
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Part 1: SAD Cohort 1 - AZD8965 (Dose 1) Participants will receive a single dose of AZD8965 (Dose 1) or matching placebo to AZD8965 on Day 1. | Drug: AZD8965 AZD8965 will be administered orally. Other: Placebo Placebo will be administered orally. |
Experimental: Part 1: SAD Cohort 2 - AZD8965 (Dose 2) Participants will receive a single dose of AZD8965 (Dose 2) or matching placebo to AZD8965 on Day 1. | Drug: AZD8965 AZD8965 will be administered orally. Other: Placebo Placebo will be administered orally. |
Experimental: Part 1: SAD Cohort 3 - AZD8965 (Dose 3) Participants will receive a single dose of AZD8965 (Dose 3) or matching placebo to AZD8965 on Day 1. | Drug: AZD8965 AZD8965 will be administered orally. Other: Placebo Placebo will be administered orally. |
Experimental: Part 1: SAD Cohort 4 - AZD8965 (Dose 4) Participants will receive a single dose of AZD8965 (Dose 4) or matching placebo to AZD8965 on Day 1. | Drug: AZD8965 AZD8965 will be administered orally. Other: Placebo Placebo will be administered orally. |
Experimental: Part 1: SAD Cohort 5 - AZD8965 (Dose 5) Participants will receive a single dose of AZD8965 (Dose 5) or matching placebo to AZD8965 on Day 1. | Drug: AZD8965 AZD8965 will be administered orally. Other: Placebo Placebo will be administered orally. |
Experimental: Part 2: MAD Cohort 1 - AZD8965 (Dose 1) Participants will receive multiple doses of AZD8965 (Dose 1) or matching placebo to AZD8965 from Day 1 to Day 8. | Drug: AZD8965 AZD8965 will be administered orally. Other: Placebo Placebo will be administered orally. |
Experimental: Part 2: MAD Cohort 2 - AZD8965 (Dose 2) Participants will receive multiple doses of AZD8965 (Dose 2) or matching placebo to AZD8965 from Day 1 to Day 8. | Drug: AZD8965 AZD8965 will be administered orally. Other: Placebo Placebo will be administered orally. |
Experimental: Part 2: MAD Cohort 3 - AZD8965 (Dose 3) Participants will receive multiple doses of AZD8965 (Dose 3) or matching placebo to AZD8965 from Day 1 to Day 8. | Drug: AZD8965 AZD8965 will be administered orally. Other: Placebo Placebo will be administered orally. |
Experimental: Part 3A: SAD Cohort 1 (Japanese) - AZD8965 (Dose 1) Japanese participants will receive a single dose of AZD8965 (Dose 1) or matching placebo to AZD8965 on Day 1. | Drug: AZD8965 AZD8965 will be administered orally. Other: Placebo Placebo will be administered orally. |
Experimental: Part 3A: SAD Cohort 2 (Japanese) - AZD8965 (Dose 2) Japanese participants will receive a single dose of AZD8965 (Dose 2) or matching placebo to AZD8965 on Day 1. | Drug: AZD8965 AZD8965 will be administered orally. Other: Placebo Placebo will be administered orally. |
Experimental: Part 3A: SAD Cohort 3 (Chinese) - AZD8965 (Dose 1) Chinese participants will receive a single dose of AZD8965 (Dose 1) or matching placebo to AZD8965 on Day 1. | Drug: AZD8965 AZD8965 will be administered orally. Other: Placebo Placebo will be administered orally. |
Experimental: Part 3B: Single and multiple ascending dose (SMAD) Cohort 1 (Japanese) - AZD8965 (Dose 1) Japanese participants will receive a single dose of AZD8965 (Dose 1) or matching placebo to AZD8965 on Day 1, followed by multiple doses of AZD8965 or matching placebo from Day 3 until Day 9. | Drug: AZD8965 AZD8965 will be administered orally. Other: Placebo Placebo will be administered orally. |
Experimental: Part 3B: SMAD Cohort 2 (Chinese) - AZD8965 (Dose 1) Chinese participants will receive a single dose of AZD8965 (Dose 1) or matching placebo to AZD8965 on Day 1, followed by multiple doses of AZD8965 or matching placebo from Day 3 until Day 9. | Drug: AZD8965 AZD8965 will be administered orally. Other: Placebo Placebo will be administered orally. |
Experimental: Part 4: Food Effect Cohort - AZD8965 Participants will receive 2 single dose treatments of AZD8965 [following an overnight fast of at least 10 hours in a fasted state or a fed state (after a high fat meal)]. | Drug: AZD8965 AZD8965 will be administered orally. |