NCT07065331

A Study of Inhaled AZD8630 in Adolescents With Asthma

A Phase I, Open-label, Single-dose Study to Evaluate the Pharmacokinetics of Inhaled AZD8630 in Adolescents With Asthma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 12 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the pharmacokinetic (PK) profile, safety, tolerability, and immunogenicity of single inhaled dose of AZD8630 administered in adolescent participants with asthma as well as the safety and performance of the dry powder inhaler.

Detailed description

This is a Phase 1, open label, single dose study that will be conducted in adolescent participants with asthma where the participants will receive AZD8630 administered via dry powder inhaler. The study will be comprised of: * A screening period. * A treatment period. * A post treatment period. * A final Follow-up visit.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	AZD8630	Single inhaled dose of AZD8630 via dry powder inhaler.
DEVICE	Dry powder inhaler	Single inhaled dose of AZD8630 via dry powder inhaler.

Timeline

• Start date: 2025-06-11
• Primary completion: 2025-09-19
• Completion: 2025-09-19
• First posted: 2025-07-15
• Last updated: 2025-10-14

Locations

9 sites across 1 country: United States

Regulatory

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