NCT06795906

A Safety, Pharmacokinetic, and Pharmacodynamic Study of Once Daily Inhaled AZD8630 in Adults With Asthma

A Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of AZD8630, Administered Once Daily Via Inhalation, for 2 Weeks, in Adults With Asthma on Medium-to-high Dose Inhaled Corticosteroids and Long-acting Beta-agonists

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a randomised, placebo-controlled, double-blinded, sponsor-unblinded study to assess the safety, pharmacokinetic (PK), and pharmacodynamic (PD) effect of AZD8630 in adult participants with asthma on medium-to-high dose inhaled corticosteroids (ICS) and long-acting beta-agonists (LABA).

Detailed description

The purpose of this study is to assess the safety, PK, and PD of AZD8630 compared to placebo in participants with asthma and elevated fractional exhaled nitric oxide (FeNO) on a combination of medium-to-high dose ICS and LABA medications. The study will comprise of: * A Screening/Enrollment Period of up to 14 to 28 days before dosing. * A Treatment Period/End of Treatment Visit. On Day 1, participants will be randomised to AZD8630 or corresponding placebo. Study intervention will be self-administered once daily up to Day 14. Participants will return to the study site for clinical and safety assessments on Day 7 and clinical and safety assessments and PK sampling on Day 14. * A Follow-up Visit 1 week after last dose.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	AZD8630	AZD8630 will be administered via dry powder inhalation (DPI).
OTHER	Placebo	Placebo will be administered via DPI.
DEVICE	Saphira device	AZD8630 or placebo will be administered to participants via Saphira device.

Timeline

• Start date: 2025-01-28
• Primary completion: 2025-06-27
• Completion: 2025-06-27
• First posted: 2025-01-28
• Last updated: 2025-10-03

Locations

3 sites across 1 country: Germany