NCT06732882

Study to Evaluate the Pharmacokinetics and Pharmacodynamics of AZD4604 Given Via the Turbuhaler® Device in Adults With Mild Asthma.

A Phase Ib, Multicentre, Randomised, Single-blind, Parallel-group, Placebo-controlled, Study to Characterise the Pharmacokinetics and Pharmacodynamics of AZD4604 Administered Via the Turbuhaler® Device in Adults With Mild Asthma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The study will investigate the Pharmacokinetic (PK), Pharmacodynamic (PD), the safety and tolerability of AZD4604, as well as to examine the effect of Fractional exhaled Nitric Oxide (FeNO) following the administration of the multiple doses of AZD4604 via Turbuhaler device.

Detailed description

This is a multicentre, randomised, placebo-controlled, single-blind study to characterise PK and PD of AZD4604, administered twice daily (BID) using a Turbuhaler or a Genuair device. Participants who have mild asthma with a raised FeNO will be randomised into the study to evaluate AZD4604 versus placebo, at 2 dose levels delivered via: a) the Turbuhaler device and b) the Genuair device. The study will be comprised of: * A screening period (Day -42 to Day-3) * Participants will be randomised to one of 5 treatment arms where participants will either receive BID doses of AZD4604 or placebo from Day 1 to Day 9 and a single dose on Day 10. * A follow-up Visit on Day 16 The total duration of the study will be for 58 days.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	AZD4604	Participants will receive AZD4604 via Genuair/Turbuhaler device.
OTHER	Placebo	Participants will receive placebo via Genuair/Turbuhaler device.
DEVICE	Genuair	Participants will either receive AZD4604 or placebo via Genuair device.
DEVICE	Turbuhaler	Participants will receive either AZD4604 or placebo via Turbuhaler device.

Timeline

• Start date: 2025-02-27
• Primary completion: 2025-05-29
• Completion: 2025-05-29
• First posted: 2024-12-13
• Last updated: 2025-06-05

Locations

10 sites across 2 countries: Germany, United Kingdom

Regulatory

• FDA-regulated drug study
• FDA-regulated device study