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

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.

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.

Key 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.