Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06519968 | A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Inhaled AZD4604 in Healthy Japanese and Chinese Participants. | PHASE1 | COMPLETED | 56 | — | — | Jul 15, 2024 | Dec 27, 2024 | Nov 17, 2025 | 1 | United Kingdom |
To assess the safety and tolerability of AZD4604 following inhaled administration of AZD4604 as single ascending doses (Parts 1a and 2a), and multiple doses (Parts 1b and 2b).
| Arm | Type | Description |
|---|---|---|
| Part 1a: AZD4604 (Dose 1) SAD | EXPERIMENTAL | Japanese participants will receive single dose of AZD4604 (Dose 1) via inhalation on Day 1. |
| Part 1a: AZD4604 (Dose 2) SAD | EXPERIMENTAL | Japanese participants will receive single dose of AZD4604 (Dose 2) via inhalation on Day 1. |
| Part 1a: AZD4604 (Dose 3) SAD | EXPERIMENTAL | Japanese participants will receive single dose of AZD4604 (Dose 3) via inhalation on Day 1. |
| Part 1a: Placebo | PLACEBO_COMPARATOR | Japanese participants will receive single dose of matching placebo to AZD4604 on Day 1. |
| Part 1b: AZD4604 (Dose 4) Multiple dose cohort | EXPERIMENTAL | 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. |
| Part 1b: Placebo | PLACEBO_COMPARATOR | Japanese participants will receive matching placebo to AZD4604 BID from day 1 to day 6 and a single dose of placebo on Day 7. |
| Part 2a: AZD4604 (Dose 1) SAD | EXPERIMENTAL | Chinese participants will receive single dose of AZD4604 (Dose 1) via inhalation on Day 1. |
| Part 2a: AZD4604 (Dose 3) SAD | EXPERIMENTAL | Chinese participants will receive single dose of AZD4604 (Dose 3) via inhalation on Day 1. |
| Part 2a: Placebo | PLACEBO_COMPARATOR | Chinese participants will receive single dose of matching placebo to AZD4604 on Day 1. |
| Part 2 b: AZD4604 (Dose 4) Multiple dose cohort | EXPERIMENTAL | Chinese participants will receive AZD4604 (Dose 4) via inhalation BID from Day 1 to Day 6 and a single dose on Day 7. |
| Part 2b: Placebo | PLACEBO_COMPARATOR | Chinese participants will receive placebo via inhalation BID from Day 1 to Day 6 and a single dose on Day 7. |
| Name | Type | Description |
|---|---|---|
| AZD4604 | DRUG | AZD4604 will be administered as Dry Powder Inhalation (DPI). |
| Placebo | DRUG | Placebo will be administered as DPI. |
Inclusion Criteria: * Japanese participants who are born in Japan, has 2 Japanese biological parents, 4 Japanese grandparents as confirmed by the interview and has lived outside Japan for less than 10 years at the time of screening. * Chinese participants who are born in China, has 2 Chinese biolog...