A First-in-Human, Randomized, Double-Blind, Placebo Controlled, Single-Center Combined Single-Ascending Dose and Multiple-Ascending Dose, Parallel Groups, Study to Assess Safety, Tolerability and Pharmacokinetics of BL-1021 in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Incidence of adverse events
研究概览
简要总结
The purpose of this study is to test the safety, tolerability and pharmacokinetics of BL-1021 in healthy volunteers. Subsequent clinical studies will be designed to test the safety and efficacy of BL-1021 in patients with neuropathic pain based on data obtained from the proposal trial described below.
详细描述
A total of 32 subjects in the single-ascending phase and 24 subjects in the multiple ascending phase, who have provided a written informed consent and comply with inclusion/exclusion criteria will participate in the study in 4 different cohorts in the first phase (cohorts A, B, C and D) and 3 different cohorts in the second phase (cohorts E, F and G), each consisting of 8 subjects.
First part dosing:
Cohort A - 10 mg Cohort B - 20 mg Cohort C - 30 mg Cohort D - 40 mg
Second part dosing:
Cohort E - X mg (X shall be determined using the results of the 1st part) Cohort F - 2X mg Cohort G - 4X mg
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 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
Cohort F - 2X mg
Part 2, multiple dose. X shall be determined using the results of part 1.
干预措施: 1021 (Drug)
Cohort A - 10 mg
干预措施: BL-1021 (Drug)
Cohort A - 10 mg
干预措施: 1021 (Drug)
Cohort B - 20 mg
干预措施: BL-1021 (Drug)
Cohort B - 20 mg
干预措施: 1021 (Drug)
Cohort C - 40 mg
干预措施: BL-1021 (Drug)
Cohort C - 40 mg
干预措施: 1021 (Drug)
Cohort D - 80 mg
干预措施: BL-1021 (Drug)
Cohort D - 80 mg
干预措施: 1021 (Drug)
Cohort E - X mg
Part 2, multiple dose. X shall be determined using the results of part 1.
干预措施: BL-1021 (Drug)
Cohort E - X mg
Part 2, multiple dose. X shall be determined using the results of part 1.
干预措施: 1021 (Drug)
Cohort F - 2X mg
Part 2, multiple dose. X shall be determined using the results of part 1.
干预措施: BL-1021 (Drug)
Cohort G - 4X mg
Part 2, multiple dose. X shall be determined using the results of part 1.
干预措施: BL-1021 (Drug)
Cohort G - 4X mg
Part 2, multiple dose. X shall be determined using the results of part 1.
干预措施: 1021 (Drug)
Placebo
In each cohort there is a placebo arm
干预措施: 1021 (Drug)
结局指标
主要结局
Incidence of adverse events
时间窗: Part 1 and 2
次要结局
- Mean change from baseline in vital signs(Part 1 and 2)
- Mean change from baseline in laboratory parameters(Part 1 and 2)
- Cmax, Tmax, AUCT, AUCI, kel, T½(Part 1 and 2)
- Dose linearity of PK parameters(part 1 and 2)