A Clinical Trial in Healthy Volunteers and Patients With Mild Asthma to Investigate a New Medicine (AZD4604) for the Treatment of Asthma

PHASE1CompletedINTERVENTIONAL
Enrollment

110

Participants

Timeline

Start Date

July 8, 2022

Primary Completion Date

January 24, 2023

Study Completion Date

January 24, 2023

Conditions
Asthma
Interventions
DRUG

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.

DRUG

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."

DRUG

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.

DRUG

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.

DRUG

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.

Trial Locations (3)

BT9 6AD

Research Site, Belfast

HA1 3UJ

Research Site, Harrow

M23 9QZ

Research Site, Manchester

Sponsors

Lead Sponsor

All Listed Sponsors
lead

AstraZeneca

INDUSTRY