A Phase 1, Randomized, Double-blind, Parallel and Placebo-controlled Single and Multiple Ascending Dose Trial Investigating Safety, Tolerability and Pharmacokinetics of LIB-01 in Healthy Participants.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- To evaluate the incidence of treatment-emergent adverse events as assessed by CTCAE in healthy male participants, following a single oral dose of LIB-01.
研究概览
简要总结
The goal of this clinical trial is to learn about the safety, tolerability and pharmacokinetics of LIB-01 in healthy male participants. The main questions it aims to answer are:
- How safe and tolerable is LIB-01 when given once or repeatedly at different dose levels.
- What are the pharmacokinetic characteristics of LIB-01
Participants will receive LIB-01 and be followed up for safety and pharmacokinetics by:
- Adverse events
- ECG
- Blood sampling for laboratory parameters and pharmacokinetic analysis
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 65 Years（Adult, Older 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
LIB-01
LIB-01 oral suspension
干预措施: LIB-01 (Drug)
Placebo
Placebo oral suspension
干预措施: Placebo (Other)
结局指标
主要结局
To evaluate the incidence of treatment-emergent adverse events as assessed by CTCAE in healthy male participants, following a single oral dose of LIB-01.
时间窗: 14 days
Frequency, seriousness and intensity of adverse events. Adverse events will be graded from 1-5 by the Common Terminology Criteria for Adverse Events (CTCAE): Grade 1, Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2, Moderate; minimal, local or non-invasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL). Grade 3, Severe or medically significant but not immediately life-threatening; hospitalisation or prolongation of hospitalisation indicated; disabling; limiting self- care ADL. Grade 4, Life-threatening consequences: urgent intervention indicated. Grade 5, Death related to AE.
To evaluate changes in vital signs in healthy male participants, following a single oral dose of LIB-01.
时间窗: 14 days
Clinically significant changes in vital signs (blood pressure, pulse, respiratory rate, body temperature).
To evaluate changes in ECG in healthy male participants, following a single oral dose of LIB-01.
时间窗: 14 days
Clinically significant changes in ECG parameters (resting heart rate \[HR\] and PQ/PR, QRS, QT and QTcF intervals).
To evaluate the incidence of treatment-emergent adverse events as assessed by CTCAE in healthy male participants, following multiple oral dosing of LIB-01.
时间窗: 28 days
Frequency, seriousness and intensity of adverse events. Adverse events will be graded from 1-5 by the Common Terminology Criteria for Adverse Events (CTCAE): Grade 1, Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2, Moderate; minimal, local or non-invasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL). Grade 3, Severe or medically significant but not immediately life-threatening; hospitalisation or prolongation of hospitalisation indicated; disabling; limiting self- care ADL. Grade 4, Life-threatening consequences: urgent intervention indicated. Grade 5, Death related to AE. Clinically significant changes in vital signs, ECG and safety laboratory measurements.
To evaluate changes in vital signs in healthy male participants, following a multiple oral dosing of LIB-01.
时间窗: 28 days
Clinically significant changes in vital signs (blood pressure, pulse, respiratory rate, body temperature).
To evaluate changes in ECG in healthy male participants, following multiple oral dosing of LIB-01.
时间窗: 28 days
Clinically significant changes in ECG parameters (resting heart rate \[HR\] and PQ/PR, QRS, QT and QTcF intervals).
次要结局
- To characterise the maximum plasma concentration of LIB-01, following a single oral dose.(3 days)
- To characterise the plasma concentration half life of LIB-01, following a single oral dose.(3 days)
- To characterise the plasma concentration area under curve of LIB-01, following a single oral dose.(3 days)
- To characterise the maximum plasma concentration of LIB-01 following multiple oral dosing.(4 days)
- To characterise the plasma concentration half life of LIB-01 following multiple oral dosing.(4 days)