A Phase 1, Double-blind, Randomized, Placebo-controlled, Sponsor-open, SAD and MAD Study in Healthy Subjects to Evaluate the Safety, Tolerability, and PK of Inhaled TD-0903, a Potential Treatment for ALI Associated With COVID-19
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Safety and Tolerability of SAD of TD-0903: Adverse Events
研究概览
简要总结
This is a phase 1 study in healthy subjects to evaluate the safety, tolerability and pharmacokinetics of single (Part A and B) and multiple (Part B) doses of inhaled TD-0903.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2 at Screening and weighs at least 50 kg.
- •Medically healthy with no clinically significant medical history, physical examination, spirometry, vital signs or ECGs.
- •Forced expiratory volume in 1 second (FEV1) ≥80%.
- •No clinically significant abnormalities in the results of laboratory evaluations.
- •Female subjects must be either of non-childbearing potential or if of childbearing potential, subject must not be pregnant or breastfeeding, and must agree to use a highly effective birth control method.
- •Male subjects must agree to use condoms, in addition to the use of highly effective pregnancy prevention measures with female partners of childbearing potential.
- •Understands the correct technique for the use the nebulizer device(s).
- •Other inclusion criteria apply
排除标准
- •History or presence of clinically significant medical or psychiatric condition.
- •Abnormal ECG measurements at Screening.
- •Any signs of respiratory tract infection within 6 weeks of Screening.
- •Subject who has a current bacterial, parasitic, fungal, or viral infection; any infection requiring hospitalization or intravenous antibiotics within 6 months prior to Screening.
- •Positive test for SARS-CoV-2
- •Subject has any condition of the oro-laryngeal or respiratory tract.
- •Uses or has used tobacco or nicotine-containing products (e.g., cigarettes, cigars, chewing tobacco, snuff, patches etc.) within 6 months prior to screening
- •Additional exclusion criteria apply
研究组 & 干预措施
TD-0903 for SAD (Part A)
6 out of 8 subjects per cohort (up to 3 cohorts) will be randomized to receive TD-0903
干预措施: TD-0903 (Drug)
Placebo for SAD (Part A)
2 out of 8 subjects per cohort (up to 3 cohorts) will be randomized to receive placebo
干预措施: Placebo (Drug)
TD-0903 for MAD (Part B)
8 out of 10 subjects per cohort (up to 3 cohorts) will be randomized to receive TD-0903
干预措施: TD-0903 (Drug)
Placebo for MAD (Part B)
2 out of 10 subjects per cohort (up to 3 cohorts) will be randomized to receive placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Safety and Tolerability of SAD of TD-0903: Adverse Events
时间窗: Day 1 to Day 8
Number and severity of treatment emergent adverse events
Safety and Tolerability of MAD of TD-0903: Adverse Events
时间窗: Day 1 to Day 14
Number and severity of treatment emergent adverse events
次要结局
- Pharmacokinetics (PK) of TD-0903 when given as a Single Ascending Dose (SAD): AUC(Day 1 through Day 4)
- Pharmacokinetics (PK) of TD-0903 when given as a Multiple Ascending Dose (MAD): AUC(Day 1 through Day 9)
- Pharmacokinetics (PK) of TD-0903 when given as a Single Ascending Dose (SAD): Tmax(Day 1 through Day 4)
- Pharmacokinetics (PK) of TD-0903 when given as a Single Ascending Dose (SAD): Cmax(Day 1 through Day 4)
- Pharmacokinetics (PK) of TD-0903 when given as a Multiple Ascending Dose (MAD): Cmax(Day 1 through Day 9)
- Pharmacokinetics (PK) of TD-0903 when given as a Multiple Ascending Dose (MAD): Tmax(Day 1 through Day 9)