NCT07065331

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1 asthma

Timeline
Completed

Started Jun 2025

Shorter than P25 for phase_1 asthma

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 11, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

June 11, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 15, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 19, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 19, 2025

Completed
Last Updated

October 14, 2025

Status Verified

October 1, 2025

Enrollment Period

3 months

First QC Date

June 11, 2025

Last Update Submit

October 10, 2025

Conditions

Asthma

Keywords

Dry powder inhalerAnti-Thymic stromal lymphopoietin

Outcome Measures

Primary Outcomes (3)

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

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

    Up to Day 9

  • Maximum observed drug concentration (Cmax)

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

    Up to Day 9

  • Time to reach peak or maximum observed concentration (Tmax)

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

    Up to Day 9

Secondary Outcomes (5)

  • Number of participants with adverse events (AEs)

    From screening until Follow-up (Day 9)

  • Incidences of anti-drug antibodies (ADA) of AZD8630

    Day 1 and Day 9

  • Number of participants with AEs associated with dry powder inhaler

    Day 1

  • Number of participants with dry powder inhaler deficiencies

    Day 1

  • Number of participants with dose administration confirmation

    Day 1

Study Arms (1)

AZD8630

EXPERIMENTAL

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

Drug: AZD8630Device: Dry powder inhaler

Interventions

AZD8630DRUG

Single inhaled dose of AZD8630 via dry powder inhaler.

AZD8630
Dry powder inhalerDEVICE

Single inhaled dose of AZD8630 via dry powder inhaler.

AZD8630

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Research Site

Bakersfield, California, 93301, United States

Location

Research Site

Miami Lakes, Florida, 33014, United States

Location

Research Site

Lafayette, Louisiana, 70508, United States

Location

Research Site

Raleigh, North Carolina, 27607, United States

Location

Research Site

Toledo, Ohio, 43617, United States

Location

Research Site

Oklahoma City, Oklahoma, 73120, United States

Location

Research Site

Spartanburg, South Carolina, 29303, United States

Location

Research Site

Boerne, Texas, 78006, United States

Location

Research Site

Salt Lake City, Utah, 84107, United States

Location

MeSH Terms

Conditions

Asthma

Interventions

Dry Powder Inhalers

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Nebulizers and VaporizersEquipment and Supplies

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2025

First Posted

July 15, 2025

Study Start

June 11, 2025

Primary Completion

September 19, 2025

Study Completion

September 19, 2025

Last Updated

October 14, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will share

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared

Time Frame
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please refer to our disclosure commitment at: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
Access Criteria
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secureresearchenvironmentVivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
More information

Locations

US(9)