A Placebo-controlled RCT in HV's Investigating the Safety, Tolerability and PK (Pharmacokinetic) of TD139, a Galectin-3 Inhibitor, Followed by an Expansion Cohort Treating Subjects With Idiopathic Pulmonary Fibrosis (IPF)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 5
- 主要终点
- Number of Participants With Adverse Events
研究概览
简要总结
This study will be divided into 2 parts. Part 1 is a randomized, double-blind, single centre, placebo-controlled, single ascending dose (SAD) phase I study designed to assess the safety, tolerability, PK and PD (Pharmacodynamic) of TD139 in up to 36 healthy male subjects. Part 2 will be a randomized, double-blind, multi-centre, placebo-controlled, multiple dose expansion cohort, designed to assess the safety, tolerability, PK and PD of TD139 in up to 24 male subjects and female subjects of non child-bearing potential with IPF.
详细描述
Up to 6 cohorts of 6 subjects will be randomly assigned in a blinded fashion to receive either a single dose of TD139 or matching placebo via DPI (dry powder inhaler) in an ascending dose fashion.
A single cohort of up to 24 patients will be randomly assigned in a blinded fashion to receive a single dose of TD139 or placebo via DPI once daily for 14 days in a 2:1 TD139 to placebo ratio. The dose of TD139 selected will be based on data from Part 1 and on pre-clinical efficacy and safety data.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
0.15 mg TD139 (Part 1)
4 Healthy Subjects are administered a single dose of 0.15mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later.
干预措施: Inhaled TD139 (Drug)
1.5 mg TD139 (Part 1)
4 Healthy Subjects are administered a single dose of 1.5mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later.
干预措施: Inhaled TD139 (Drug)
3 mg TD139 (Part 1)
4 Healthy Subjects are administered a single dose of 3mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later.
干预措施: Inhaled TD139 (Drug)
10 mg TD139 Part 1
4 Healthy Subjects are administered a single dose of 10mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later.
干预措施: Inhaled TD139 (Drug)
20 mg TD139 Part 1
4 Healthy Subjects are administered a single dose of 20mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later.
干预措施: Inhaled TD139 (Drug)
50 mg TD139 Part 1
4 Healthy Subjects are administered a single dose of 50mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later.
干预措施: Inhaled TD139 (Drug)
Placebo Part 1
12 Healthy Subjects are administered placebo inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later.
干预措施: Placebo (Drug)
0.3 mg TD139 Part 2
5 Patients with IPF are administered a single dose of 0.3mg TD139 once daily for 14 days inhaled as a dry powder.
干预措施: Inhaled TD139 (Drug)
3 mg TD139 Part 2
5 Patients with IPF are administered a single dose of 3mg TD139 once daily for 14 days inhaled as a dry powder.
干预措施: Inhaled TD139 (Drug)
10 mg TD139 Part 2
5 Patients with IPF are administered a single dose of 10mg TD139 once daily for 14 days inhaled as a dry powder.
干预措施: Inhaled TD139 (Drug)
Placebo Part 2
9 Patients with IPF are administered placebo inhaled as a dry powder.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants With Adverse Events
时间窗: 0 - 30 days
Number of participants reporting Adverse Events from the date of first dose, until 30 days post first dose.
次要结局
未报告次要终点