Study identifier:D6830C00001
ClinicalTrials.gov identifier:NCT05110976
EudraCT identifier:2021-004000-18
CTIS identifier:N/A
Phase I, Randomised, Blinded, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD8630 in Healthy Adult Subjects (Part A) and Adults with Asthma on Medium to High Dose Inhaled Corticosteroids and Long-acting Beta-agonists (Part B)
asthma
Phase 1
Yes
AZD8630, Placebo
All
181
Interventional
18 Years - 75 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Sequential Assignment
Masking: -
Primary Purpose: Other
Verified 01 Oct 2024 by AstraZeneca
AstraZeneca
-
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Part A1: SAD (AZD8630) Healthy participants will receive single inhaled doses 1 to 5 of AZD8630. | Drug: AZD8630 Participants will receive Inhaled or IV doses of AZD8630 as per the arm they are assigned. |
Experimental: Part A1: IV (AZD8630) Healthy participants will receive a single IV dose of AZD8630. | Drug: AZD8630 Participants will receive Inhaled or IV doses of AZD8630 as per the arm they are assigned. |
Placebo Comparator: Part A1: IV (Placebo) Healthy participants will receive single IV dose of Placebo. | Drug: Placebo Participants will receive Inhaled or IV doses of placebo as per the arm they are assigned. |
Experimental: Part A2: SAD (AZD8630) Healthy participants of Chinese and Japanese ethnicity will receive single inhaled dose 5 of AZD8630. | Drug: AZD8630 Participants will receive Inhaled or IV doses of AZD8630 as per the arm they are assigned. |
Experimental: Part A3: MAD (AZD8630) Healthy participants will receive once daily inhaled doses 3, 4, and 5 of AZD8630. | Drug: AZD8630 Participants will receive Inhaled or IV doses of AZD8630 as per the arm they are assigned. |
Experimental: Part A4: MAD (AZD8630) Healthy participants of Chinese and Japanese ethnicity will receive once daily inhaled dose 5 of AZD8630. | Drug: AZD8630 Participants will receive Inhaled or IV doses of AZD8630 as per the arm they are assigned. |
Placebo Comparator: Part A: SAD (Placebo) Healthy participants and healthy participants of Chinese and Japanese ethnicity will receive single inhaled doses of placebo. | Drug: Placebo Participants will receive Inhaled or IV doses of placebo as per the arm they are assigned. |
Placebo Comparator: Part A: MAD (Placebo) Healthy participants and healthy participants of Chinese and Japanese ethnicity will receive once daily inhaled dose of placebo. | Drug: Placebo Participants will receive Inhaled or IV doses of placebo as per the arm they are assigned. |
Experimental: Part B (AZD8630) Participants with asthma will be randomized to one of 3 inhaled dose levels 3, 6, and 7 of AZD8630 once daily. | Drug: AZD8630 Participants will receive Inhaled or IV doses of AZD8630 as per the arm they are assigned. |
Placebo Comparator: Part B (Placebo) Participants with asthma will receive once daily inhaled dose of placebo. | Drug: Placebo Participants will receive Inhaled or IV doses of placebo as per the arm they are assigned. |