A Study of Inhaled AZD8630 in Adolescents With Asthma (APkITA)

AstraZeneca

Status and phase

Enrolling

Phase 1

Conditions

Asthma

Treatments

Drug: AZD8630

Device: Dry powder inhaler

Study type

Interventional

Funder types

Industry

Identifiers

NCT07065331

D6830C00005

Details and patient eligibility

About

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.

Full 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.

Enrollment

19 estimated patients

Sex

All

Ages

12 to 17 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.