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 Jan 2025 by AstraZeneca
AstraZeneca
PAREXEL
The purpose of this study is to investigate the safety, tolerability, and pharmacokinetics (PK) of AZD4604 when administered as single or multiple inhaled doses to healthy Japanese and Chinese participants.
This study will comprise of two parts: Part 1 and Part 2 Part 1 will investigate the safety, tolerability, and PK of inhaled AZD4604 following single ascending and multiple doses in healthy Japanese participants. Part 1a will include three single ascending dose (SAD) cohorts and Part 1b will include one multiple dose cohort. Part 2 will investigate the safety, tolerability, and PK of inhaled AZD4604 following single ascending and multiple doses in healthy Chinese participants. Part 2a will include two SAD cohort and Part 2b will include one multiple dose cohort. Part 1a and Part 2a will comprise of: 1. A Screening Visit within 28 days before dosing. 2. A treatment period (Day 1 to Day 7) 3. A final assessment on Day 7 Part 1b and Part 2b will comprise of: 1. A Screening Visit within 28 days before dosing. 2. A treatment period (Day 1 to Day 13) 3. A final assessment on Day 13
Location
Location
Harrow, United Kingdom, HA1 3UJ
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. |
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