A Phase 1 Randomized, Double-blind, Placebo-controlled, Crossover Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of a Single-dose of ASY202 in Adults With Asthma
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 5
- 主要终点
- Effect of a single dose of ASY202 2 mg compared with placebo on pulmonary function in adults with asthma.
研究概览
简要总结
This is a phase 1 study, randomized, double-blind, placebo-controlled, 2 treatment, 2 period crossover study to evaluate the pharmacokinetics, safety, and tolerability of a single inhaled dose of ASY202 in adults with stable asthma.
Following screening, eligible participants will be enrolled and randomized to one of two treatment sequences. Participants will receive a single inhaled dose of ASY202 and a single inhaled dose of placebo, each administered once during separate study periods.
During each treatment period, subjects will stay in the clinical research unit for safety monitoring and PK assessments, including serial blood sampling, spirometry, vital signs, clinical laboratory tests, and ECGs. Each period will include post dose assessments for up to 24 hours.
Participants will return for their next treatment period after a washout interval to ensure complete clearance of study medication. All subjects will receive both treatments over the course of the study.
A follow-up visit will occur after the last dose to assess ongoing safety and tolerability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18-55 years
- •Diagnosed asthma
- •Stable asthma treatment
- •Non smoker
- •BMI 18.5-35 kg/m²
- •Women of childbearing potential and men agree to use acceptable contraception
排除标准
- •Asthma exacerbation requiring systemic steroids, ER visit, or hospitalization within 3 months
- •Respiratory tract infection within 4 weeks prior to screening
- •Use of oral or IV corticosteroids
- •Use of prohibited medications (e.g., CYP3A4 modulators, triptans, vasoconstrictors, QT prolongers, theophylline, systemic steroids)
- •Other lung diseases (e.g., Chronic Obstructive Pulmonary Disease (COPD)) or conditions interfering with spirometry
- •Unstable asthma or unresolved safety concerns before dosing
- •Clinically significant cardiovascular disease or ECG abnormalities contraindicating DHE
- •Three or more risk factors for Coronary Artery Disease (CAD) (hypertension, hypercholesterolemia, smoker, obesity, diabetes, strong family history of CAD, females who are surgically or physiologically postmenopausal, or males who are over 40 years of age)
- •Pregnancy, breastfeeding, or unwillingness to use required contraception
研究组 & 干预措施
ASY202, then placebo
ASY202 is a pre-metered drug-device combination product containing DHE dry powder formulation for oral inhalation, delivered via a dry powder inhaler (DPI) device. In Treatment Period 1, participants will receive ASY202, followed by a washout period and subsequent administration of placebo in Treatment Period 2. The placebo consists of an inactive inhalation powder delivered via a matching DPI device.
干预措施: Placebo (Combination Product)
Placebo, then ASY202
In Treatment Period 1, participants will receive placebo inhalation powder delivered via a dry powder inhaler (DPI) device, followed by a washout period and subsequent administration of ASY202 in Treatment Period 2.
干预措施: ASY202 (Combination Product)
ASY202, then placebo
ASY202 is a pre-metered drug-device combination product containing DHE dry powder formulation for oral inhalation, delivered via a dry powder inhaler (DPI) device. In Treatment Period 1, participants will receive ASY202, followed by a washout period and subsequent administration of placebo in Treatment Period 2. The placebo consists of an inactive inhalation powder delivered via a matching DPI device.
干预措施: ASY202 (Combination Product)
Placebo, then ASY202
In Treatment Period 1, participants will receive placebo inhalation powder delivered via a dry powder inhaler (DPI) device, followed by a washout period and subsequent administration of ASY202 in Treatment Period 2.
干预措施: Placebo (Combination Product)
结局指标
主要结局
Effect of a single dose of ASY202 2 mg compared with placebo on pulmonary function in adults with asthma.
时间窗: Post dose 5 minutes, 15 minutes, 40 minutes, 1hour, 2 hours and 4 hours.
Percentage change from baseline in FEV1 over time measured by spirometry at predefined timepoints post-dose (5 minutes, 15 minutes, 40 minutes, 1 hour, 2 hours and 4 hours), following administration of investigational product.
次要结局
- Effect of a single dose of ASY202 2 mg compared with placebo on additional pulmonary function in adults with asthma.(Post dose 5 minutes, 15 minutes, 40 minutes, 1 hour, 2 hours and 4 hours.)