AZD8630
DrugSingle inhaled dose of AZD8630 via dry powder inhaler.
NCT Number: NCT07065331
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.
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Notify Me12 year–17 year
All sexes
Interventional
Phase 1
Research Site, Bakersfield, California, United States
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria:
Key Exclusion Criteria:
Single inhaled dose of AZD8630 via dry powder inhaler.
Single inhaled dose of AZD8630 via dry powder inhaler.
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.
Time frame: Up to Day 9
The Cmax of AZD8630 after administered as single inhaled dose in adolescent participants with asthma will be evaluated.
Time frame: Up to Day 9
The Tmax of AZD8630 after administered as single inhaled dose in adolescent participants with asthma will be evaluated.
Time frame: From screening until Follow-up (Day 9)
The safety and the tolerability of AZD8630 in adolescent participants with asthma will be evaluated.
Time frame: Day 1 and Day 9
The immunogenicity of AZD8630 in adolescent participants with asthma will be evaluated.
Time frame: Day 1
The safety and the performance of the dry powder inhaler device in adolescent participants with asthma will be evaluated.
Time frame: Day 1
The safety and the performance of the dry powder inhaler in adolescent participants with asthma will be evaluated.
Time frame: Day 1
The safety and the performance of the dry powder inhaler in adolescent participants with asthma will be evaluated.
AstraZeneca
Industry
A Phase I, Open-label, Single-dose Study to Evaluate the Pharmacokinetics of Inhaled AZD8630 in Adolescents With Asthma
Acronym: APkITA
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.
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