A Study of Inhaled AZD8630 in Adolescents With Asthma

Not Applicable

Recruiting

• Conditions: Asthma
• Interventions: Drug: AZD8630; Device: Dry powder inhaler

• Registration Number: NCT07065331
• Lead Sponsor: AstraZeneca

Brief 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.

Study Timeline

• Status Verified: 2025-06
• Study Start: 2025-06-11
• Study First Submitted: 2025-06-11
• Study First Submitted QC: 2025-07-03
• Last Update Submitted: 2025-07-03
• Study First Posted: 2025-07-15
• Last Update Posted: 2025-07-15
• Primary Completion: 2026-02-25
• Study Completion: 2026-02-25

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

• Physician prescribed daily use of asthma medication.
• Pre-bronchodilator Forced expiratory volume in one second (FEV1) ≥ 50% of the predicted normal value.
• Asthma control questionnaire-5 (ACQ-5) < 1.5 at Screening and Study Day 1.

Key

Exclusion Criteria

• History of any clinically important disease or disorder.
• History of any chronic respiratory disorders (except asthma).
• Acute exacerbation of asthma within 4 weeks of Screening.
• Life -threatening asthma.
• Completed treatment for respiratory infection with antibiotics within 4 weeks of Screening.
• History of acquired or inherited immunodeficiency disorders.
• Oral immunotherapy, including stable maintenance dose allergen-specific oral immunotherapy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AZD8630	AZD8630	Participants will receive single inhaled dose of AZD8630 on Day 1 via dry powder inhaler.
AZD8630	Dry powder inhaler	Participants will receive single inhaled dose of AZD8630 on Day 1 via dry powder inhaler.

Primary Outcome Measures

Name	Time	Method
Area under the serum concentration-time curve from time zero to 24 hours (AUC0-24)	Up to Day 9	The AUC0-24 of AZD8630 after administered as single inhaled dose in adolescent participants with asthma will be evaluated.
Maximum observed drug concentration (Cmax)	Up to Day 9	The Cmax of AZD8630 after administered as single inhaled dose in adolescent participants with asthma will be evaluated.
Time to reach peak or maximum observed concentration (Tmax)	Up to Day 9	The Tmax of AZD8630 after administered as single inhaled dose in adolescent participants with asthma will be evaluated.

Secondary Outcome Measures

Name	Time	Method
Number of participants with adverse events (AEs)	From screening until Follow-up (Day 9)	The safety and the tolerability of AZD8630 in adolescent participants with asthma will be evaluated.
Incidences of anti-drug antibodies (ADA) of AZD8630	Day 1 and Day 9	The immunogenicity of AZD8630 in adolescent participants with asthma will be evaluated.
Number of participants with AEs associated with dry powder inhaler	Day 1	The safety and the performance of the dry powder inhaler device in adolescent participants with asthma will be evaluated.
Number of participants with dry powder inhaler deficiencies	Day 1	The safety and the performance of the dry powder inhaler in adolescent participants with asthma will be evaluated.
Number of participants with dose administration confirmation	Day 1	The safety and the performance of the dry powder inhaler in adolescent participants with asthma will be evaluated.

Trial Locations

Locations (1)

Research Site; 🇺🇸 Madison, Wisconsin, United States