Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Assess the Safety and Tolerability, Pharmacokinetics, and Pharmacodynamics of Compound LB54640 in Healthy Overweight and Obese Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Change from baseline in vital signs (blood pressure)
研究概览
简要总结
The aim of this 4-weeks randomized double-blind placebo-controlled single and multiple ascending dose study is to assess the Safety and Tolerability of LB54640 in Healthy overweight and obese subjects
详细描述
The study was conducted in 2 parts:
Part 1 (Single Ascending Dose) This study part included 6 sequential dose cohorts (S1-S6), enrolling 8 healthy subjects per cohort. Cohort S3 was evaluate the effect of food.
Part 2 (Multiple Ascending Dose) This part included 7 sequential dose cohorts (M1-M7), enrolling 8 subjects per cohort. Cohorts was evaluate safety, Pharmacokinetics and Pharmacodynamics parameters in healthy overweight and obese subjects. They were dosed once daily for 28 days with LB54640 or placebo.
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
- Double (Participant, Investigator)
盲法说明
Double blind, there will be unblinded pharmacist for investigational product distribution.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults ≥ 18 to ≤ 70 years.
- •Body mass index (BMI) ≥ 27 kg/m2, with stable body weight by history for 3 months (defined as change < 5%)
- •HbA1c < 6.5%.
- •Female subjects must be non-pregnant and non-lactating. Females of childbearing potential must use at least two of the medically accepted contraceptive methods, table at least 4 weeks prior to the screening.
- •Ability to provide written informed consent.
排除标准
- •History or current diagnosis with T1DM or T2DM.
- •History or current diagnosis of any malignancy.
- •History of pheochromocytoma or insulinoma.
- •History or current diagnosis of cardiac dysrhythmias or heart disease
- •History of surgical treatment for obesity or any other gastrointestinal surgery
- •History of major depression, anxiety, suicidal behavior or attempts, or other psychiatric disorder.
- •Use of approved weight-lowering pharmacotherapy
- •Has a clinically significant history of suicidal ideation or suicidal behavior as assessed
研究组 & 干预措施
LB54640
5 mg, 25 mg and 200 mg strengths
Subjects will be administered once daily and duration vary per each cohorts.
Single Ascending Dose (SAD) cohorts : 1 day
- SAD 1 10mg
- SAD 2 25mg
- SAD 3 50mg (Food effect cohort)
- SAD 4 100mg
- SAD 5 200mg
- SAD 6 400mg
healthy Multiple Ascending Dose (MAD) cohorts: 28days
- MAD 1 10mg
- MAD 2 25mg
- MAD 3 50mg
- MAD 4 100mg
- MAD 5 200mg
- MAD 6 400mg
- MAD 7 600mg
干预措施: LB64640 (Drug)
Placebo
matching placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline in vital signs (blood pressure)
时间窗: Through study completion upto 6weeks depending on cohorts
Absolute values and changes from baseline (BP assessed by 24-hour ambulatory blood pressure monitoring (ABPM);systolic pressure and diastolic pressure will be assessed
Change from baseline in vital signs (heart rate)
时间窗: Through study completion upto 6weeks depending on cohorts
Absolute values and changes from baseline (HR assessed by 24-hour ambulatory electrocardiography monitoring (12-lead cardiac telemetry; central reader))
Change from baseline in vital signs (weight in kilograms, height in meters)
时间窗: Through study completion upto 6weeks depending on cohorts
weight and height will be combined to report BMI in kg/m\^2
Incidence and severity of adverse events (AEs)
时间窗: Through study completion upto 6weeks depending on cohorts
Number of subjects who experienced adverse events and severity of adverse events
Incidence and severity of adverse events of special interest (AESIs) in Part 2 (MAD)
时间窗: Through study completion upto 6weeks depending on cohorts
Number of subjects who experienced adverse events of special interest (AESIs)
次要结局
- Pharmacokinetics profiles in urine for single ascending dose cohort(Through study completion upto 1week depending on cohorts)
- Pharmacokinetics profiles in Plasma for single ascending dose cohort(Through study completion upto 1week during the single ascending dose cohort)
- Pharmacokinetics profiles in plasma for multiple ascending dose cohort(Through study completion upto 2weeks)