Study identifier:D8210C00002
ClinicalTrials.gov identifier:NCT06519968
EudraCT identifier:N/A
CTIS identifier:N/A
A Single-blind, Randomised, Placebo-controlled Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Inhaled AZD4604 Following Single Ascending and Multiple Doses in Healthy Japanese and Chinese Participants
Healthy Participants
Phase 1
Yes
AZD4604, Placebo
All
56
Interventional
18 Years - 55 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Sequential Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Sept 2024 by AstraZeneca
AstraZeneca
PAREXEL
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Part 1a: AZD4604 (Dose 1) SAD Japanese participants will receive single dose of AZD4604 (Dose 1) via inhalation on Day 1. | Drug: AZD4604 AZD4604 will be administered as Dry Powder Inhalation (DPI). |
Experimental: Part 1a: AZD4604 (Dose 2) SAD Japanese participants will receive single dose of AZD4604 (Dose 2) via inhalation on Day 1. | Drug: AZD4604 AZD4604 will be administered as Dry Powder Inhalation (DPI). |
Experimental: Part 1a: AZD4604 (Dose 3) SAD Japanese participants will receive single dose of AZD4604 (Dose 3) via inhalation on Day 1. | Drug: AZD4604 AZD4604 will be administered as Dry Powder Inhalation (DPI). |
Placebo Comparator: Part 1a: Placebo Japanese participants will receive single dose of matching placebo to AZD4604 on Day 1. | Drug: Placebo Placebo will be administered as DPI. |
Experimental: Part 1b: AZD4604 (Dose 4) Multiple dose cohort Japanese participants will receive AZD4604 (Dose 4) via inhalation twice daily (BID) from Day 1 to Day 6 and a single dose on Day 7. | Drug: AZD4604 AZD4604 will be administered as Dry Powder Inhalation (DPI). |
Placebo Comparator: Part 1b: Placebo Japanese participants will receive matching placebo to AZD4604 BID from day 1 to day 6 and a single dose of placebo on Day 7. | Drug: Placebo Placebo will be administered as DPI. |
Experimental: Part 2a: AZD4604 (Dose 1) SAD Chinese participants will receive single dose of AZD4604 (Dose 1) via inhalation on Day 1. | Drug: AZD4604 AZD4604 will be administered as Dry Powder Inhalation (DPI). |
Experimental: Part 2a: AZD4604 (Dose 3) SAD Chinese participants will receive single dose of AZD4604 (Dose 3) via inhalation on Day 1. | Drug: AZD4604 AZD4604 will be administered as Dry Powder Inhalation (DPI). |
Placebo Comparator: Part 2a: Placebo Chinese participants will receive single dose of matching placebo to AZD4604 on Day 1. | Drug: Placebo Placebo will be administered as DPI. |
Experimental: Part 2 b: AZD4604 (Dose 4) Multiple dose cohort Chinese participants will receive AZD4604 (Dose 4) via inhalation BID from Day 1 to Day 6 and a single dose on Day 7. | Drug: AZD4604 AZD4604 will be administered as Dry Powder Inhalation (DPI). |
Placebo Comparator: Part 2b: Placebo Chinese participants will receive placebo via inhalation BID from Day 1 to Day 6 and a single dose on Day 7. | Drug: Placebo Placebo will be administered as DPI. |