Skip to main content
OpenTrials
Completed

NCT Number: NCT07065331

A Study 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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site, Bakersfield, California, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AZD8630

Drug

Single inhaled dose of AZD8630 via dry powder inhaler.

Dry Powder Inhaler

Device

Single inhaled dose of AZD8630 via dry powder inhaler.

Primary outcomes

  1. Area under the serum concentration-time curve from time zero to 24 hours (AUC0-24)

    Time frame: Up to Day 9

    The AUC0-24 of AZD8630 after administered as single inhaled dose in adolescent participants with asthma will be evaluated.

  2. Maximum observed drug concentration (Cmax)

    Time frame: Up to Day 9

    The Cmax of AZD8630 after administered as single inhaled dose in adolescent participants with asthma will be evaluated.

  3. Time to reach peak or maximum observed concentration (Tmax)

    Time frame: Up to Day 9

    The Tmax of AZD8630 after administered as single inhaled dose in adolescent participants with asthma will be evaluated.

Secondary outcomes

  1. Number of participants with adverse events (AEs)

    Time frame: From screening until Follow-up (Day 9)

    The safety and the tolerability of AZD8630 in adolescent participants with asthma will be evaluated.

  2. Incidences of anti-drug antibodies (ADA) of AZD8630

    Time frame: Day 1 and Day 9

    The immunogenicity of AZD8630 in adolescent participants with asthma will be evaluated.

  3. Number of participants with AEs associated with dry powder inhaler

    Time frame: Day 1

    The safety and the performance of the dry powder inhaler device in adolescent participants with asthma will be evaluated.

  4. Number of participants with dry powder inhaler deficiencies

    Time frame: Day 1

    The safety and the performance of the dry powder inhaler in adolescent participants with asthma will be evaluated.

  5. Number of participants with dose administration confirmation

    Time frame: Day 1

    The safety and the performance of the dry powder inhaler in adolescent participants with asthma will be evaluated.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Acronym: APkITA

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 15, 2025
Registry last updated
Oct 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.