A Phase 1, Randomized, Double-Blinded, Placebo-Controlled, 3-Part Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TD-8236 by Inhalation of Single Ascending Doses in Healthy Subjects (Part A) and Multiple Ascending Doses in Subjects With Stable, Mild Asthma (Part B), and Stable, Moderate-to-Severe Asthma (Part C)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- To assess the safety and tolerability of SAD of TD-8236 by assessing the number, severity and type of treatment emergent adverse events
研究概览
简要总结
This is a Phase 1, randomized, double-blinded, placebo controlled study. The study consists of 3 parts: Part A is a single ascending dose (SAD) study in healthy subjects, Part B is a multiple ascending dose (MAD) study in subjects with stable, mild asthma, and Part C (Biomarker) is a multiple dose study in subjects with stable, moderate-to-severe asthma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female, 18 - 60 years old
- •Willing and able to give informed consent and comply with the study
- •Body mass index (BMI) 18 to 32 kg/m2 and weighs at least 50 kg
- •Women of child bearing potential must have a negative pregnancy test and use a highly efficient birth control method
- •Pre-bronchodilator FEV ≥ 70% predicted for MAD cohorts and >40% predicted for biomarker cohorts
- •Treatment with inhaled corticosteroids with or without long acting beta agonists
- •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
- •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 for MAD (Part B)
6 out of 8 subjects per cohort (up to 6 cohorts) will be randomized to receive TD-8236.
干预措施: TD-8236 (Drug)
TD-8236 for SAD (Part A)
6 out of 8 subjects per cohort (up to 5 cohorts) will be randomized to receive TD-8236
干预措施: TD-8236 (Drug)
Placebo for SAD (Part A)
2 out of 8 subjects per cohort (up to 5 cohorts) will be randomized to receive placebo
干预措施: Placebo (Drug)
Placebo for MAD (Part B)
2 out of 8 subjects per cohort (up to 6 cohorts) will be randomized to receive placebo.
干预措施: Placebo (Drug)
TD-8236 for Biomarker (Part C)
8 subjects in each of 2 biomarker cohorts will be randomized to receive TD-8236.
干预措施: TD-8236 (Drug)
Placebo for Biomarker (Part C)
8 subjects in 1 biomarker cohort will be randomized to receive placebo.
干预措施: Placebo (Drug)
结局指标
主要结局
To assess the safety and tolerability of SAD of TD-8236 by assessing the number, severity and type of treatment emergent adverse events
时间窗: Day 1 through Day 8
To assess the safety and tolerability of MAD of TD-8236 by assessing the number, severity and type of treatment emergent adverse events
时间窗: Day 1 through Day 14
次要结局
- Pharmacokinetics (PK) of TD-8236 when given as a Single Ascending Dose (SAD): Maximum observed concentration (Cmax)(Day 1 through Day 4)
- Pharmacokinetics (PK) of TD-8236 when given as a Single Ascending Dose (SAD): Time to reach maximum observed concentration (Tmax)(Day 1 through Day 4)
- Pharmacokinetics (PK) of TD-8236 when given as a Multiple Ascending Dose (MAD): Area under the plasma concentration-time curve (AUC)(Day 1 through Day 9)
- Pharmacokinetics (PK) of TD-8236 when given as a Multiple Ascending Dose (MAD): Maximum observed concentration (Cmax)(Day 1 through Day 9)
- Pharmacokinetics (PK) of TD-8236 when given as a Single Ascending Dose (SAD): Area under the plasma concentration-time curve (AUC)(Day 1 through Day 4)
- Pharmacokinetics (PK) of TD-8236 when given as a Multiple Ascending Dose (MAD): Time to reach maximum observed concentration (Tmax)(Day 1 through Day 9)