Asthma
Conditions
Keywords
Dry powder inhaler, Anti-Thymic stromal lymphopoietin
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.
Interventions
DRUGAZD8630
Single inhaled dose of AZD8630 via dry powder inhaler.
DEVICEDry powder inhaler
Single inhaled dose of AZD8630 via dry powder inhaler.
Sponsors
AstraZeneca
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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. |
| 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. |
| 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. |
Countries
United States
Outcome results
None listed