110
Participants
Start Date
July 8, 2022
Primary Completion Date
January 24, 2023
Study Completion Date
January 24, 2023
AZD4604 for inhalation via DPI
Healthy volunteers will receive AZD4604 administered with a DPI. The dose is expected to be administered between 10 to 45 minutes, depending upon dose. The dose will be administered after an overnight fast of at least 10 hours. Healthy volunteers will be allowed to drink water to prevent dehydration until 1 hour before dosing.
Placebo for AZD4604 for inhalation via DPI
"Part 1a: An additional cohort of healthy volunteers will receive a placebo administered with a DPI.~Part 2: Healthy volunteers will receive placebo administered with a DPI. They will receive BID doses on Day 1 to Day 6, and a single dose will be administered on Day 7.~Part 3: Patients will receive placebo administered with a DPI. They will receive BID doses on Day 1 to Day 9, and a single dose will be administered on Day 10."
AZD4604 for IV administration
Healthy volunteers will receive a single IV dose of AZD4604 administered over 20 minutes. The dose will be administered after an overnight fast of at least 10 hours. Healthy volunteers will be allowed to drink water to prevent dehydration until 1 hour before dosing.
AZD4604 for oral administration
Healthy volunteers will receive a single PO dose of AZD4604. The dose will be administered after an overnight fast of at least 10 hours. Healthy volunteers will be allowed to drink water to prevent dehydration until 1 hour before dosing.
AZD4604 for inhalation via DPI
Patients with mild asthma will also receive AZD4604 administered with a DPI. Patients will receive BID doses on Day 1 to Day 9 (morning and evening with 12-hour intervals between doses), and a single morning dose will be administered on Day 10. On Day 1 and Day 10, the morning dose will be administered after an overnight fast of 10 hours. For all other doses, the dose will be administered after a 1-hour fast.
Research Site, Belfast
Research Site, Harrow
Research Site, Manchester
Lead Sponsor
AstraZeneca
INDUSTRY