A Phase I, Open-label, Single-dose Study to Evaluate the Pharmacokinetics of Inhaled AZD8630 in Adolescents With Asthma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Area under the serum concentration-time curve from time zero to 24 hours (AUC0-24)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
AZD8630
Participants will receive single inhaled dose of AZD8630 on Day 1 via dry powder inhaler.
干预措施: AZD8630 (Drug)
AZD8630
Participants will receive single inhaled dose of AZD8630 on Day 1 via dry powder inhaler.
干预措施: Dry powder inhaler (Device)
结局指标
主要结局
Area under the serum concentration-time curve from time zero to 24 hours (AUC0-24)
时间窗: 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)
时间窗: 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)
时间窗: Up to Day 9
The Tmax of AZD8630 after administered as single inhaled dose in adolescent participants with asthma will be evaluated.
次要结局
- 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)