NCT04150341已完成2 期
A Randomized, Double-blind, Placebo-controlled, 3-period Crossover Study to Evaluate the Effects of Repeated Doses of Inhaled TD-8236 and Impact on Airway Responses Following Allergen Challenge in Patients With Asthma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Area Under the Curve of Change From Baseline in Forced Expiratory Volume (in 1 Second) (FEV1) From 3 to 8 Hours After Inhaled Allergen Challenge at Day 14
研究概览
简要总结
This will be a randomized, double-blind, placebo-controlled study. The study will use a three-period, six-sequence, complete-block, cross-over study design to characterize two doses of inhaled TD-8236 compared to placebo in subjects with mild asthma and a known response to an allergen. Each of the three periods will be 14 days, followed by a washout period before the next period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, 18 to 65 years of age
- •Willing and able to give informed consent and comply with study requirements
- •Documented physician-diagnosed asthma for ≥ 4 months prior to Screening
- •Body mass index (BMI) ≥ 18.0 and ≤ 35.0 kg/m2 at Screening and weighs ≥ 50 kg at Screening.
- •Women of child bearing potential must have a negative pregnancy test
- •Males and females must use a highly efficient birth control method
- •Pre-bronchodilator FEV1 ≥ 70% predicted
- •Documented allergy to at least one common allergen
- •Dual responder to inhaled bronchial challenges
- •Additional inclusion criteria apply
排除标准
- •Positive for hepatitis A, B or C, HIV or tuberculosis
- •Clinically significant abnormalities of laboratory evaluations
- •Have abnormal ECG measurements
- •Any sign of respiratory tract infection within 6 weeks of screening
- •Have a current bacterial, parasitic, fungal or viral infection
- •History of life-threatening asthma
- •Uses or have used tobacco or nicotine-containing products within 6 months prior to screening
- •Additional exclusion criteria apply
研究组 & 干预措施
TD-8236 Dose A (low dose)
Experimental
TD-8236 Dose A (QD x 14 days)
干预措施: TD-8236 (Drug)
TD-8236 Dose B (high dose)
Experimental
TD-8236 Dose B (QD x 14 days)
干预措施: TD-8236 (Drug)
Placebo
Placebo Comparator
Placebo (QD x 14 days)
干预措施: Placebo (Drug)
结局指标
主要结局
Area Under the Curve of Change From Baseline in Forced Expiratory Volume (in 1 Second) (FEV1) From 3 to 8 Hours After Inhaled Allergen Challenge at Day 14
时间窗: Day 14 of treatment period: 3 to 8 hours after allergen challenge
Values are reported as a weighted mean derived by calculating the AUC change from baseline over the relative time interval, divided by the time interval.
次要结局
- Area Under the Curve of Percentage Change From Baseline in Forced Expiratory Volume (in 1 Second) (FEV1) From 3 to 8 Hours After Inhaled Allergen Challenge at Day 14(Day 14 of treatment period: 3 to 8 hours after allergen challenge)
- Area Under the Concentration-time Curve Over One 24-hour Dosing Interval (AUC0-24) of TD-8236 in Plasma(Day 14 of treatment period: Pre-dose and 0.5, 1, 2, 4, 6, 8 and 24 hours post-dose)
- Maximum Decline in Forced Expiratory Volume (in 1 Second) (FEV1) From 3 to 8 Hours After Inhaled Allergen Challenge at Day 14(Day 14 of treatment period: 3 to 8 hours after allergen challenge)
- Maximum Percentage Decline in Forced Expiratory Volume (in 1 Second) (FEV1) From 3 to 8 Hours After Inhaled Allergen Challenge at Day 14(Day 14 of treatment period: 3 to 8 hours after allergen challenge)
- Maximum Observed Plasma Concentration (Cmax) of TD-8236 in Plasma During Dosing Interval(Day 14 of treatment period: Pre-dose and 0.5, 1, 2, 4, 6, 8 and 24 hours post-dose)
- Time to Maximum Observed Concentration (Tmax) of TD-8236 in Plasma Over a Dosing Interval(Day 14 of treatment period: Pre-dose and 0.5, 1, 2, 4, 6, 8 and 24 hours post-dose)
- Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)(Day 1 to end of follow-up (up to approximately 98 days))
研究者
研究点 (1)
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