A Phase I, Single Ascending and Multiple Ascending Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LIFE-001
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Adverse events
研究概览
简要总结
The goal of this clinical trial is to learn if LIFE-001 is safe and tolerable for healthy adult volunteers.
详细描述
Participants will attend the site where dosing will be done subcutaneously via direct staff administration and they can only participate in one of the following cohorts:
Single Ascending Dose (SAD) Cohorts 1-10: Screening/baseline period of up to 28 days with a 6-day inpatient say and total duration up to 51 days. Single ascending doses of LIFE-001 between 10mg and up to 1500mg or placebo (Day 1) administered under fasting conditions. Increases will be based on safety and tolerability at each dose level.
Multiple Ascending Dose (MAD) Cohorts 1-4: Screening/baseline period of up to 28 days with two 6-day inpatient says and total duration up to 91 days. Four doses of LIFE-001 between 50mg and 300mg or placebo on Days 1, 8, 15 and 22 administered under fasting conditions.
MAD Cohorts 5-6: Screening/baseline period of up to 28 days with two 5-day inpatient says and total duration up to 73 days. Participants will receive a dose of LIFE-001 or placebo between 50mg and up to 1500mg via SC injection(s) QW on Days 1, 8, 15, and 22 or BIW on Days 1, 4, 8, 11, 15, 18, and 22 (total 7 doses), as determined by the SRC.
Exact dose of LIFE-001 for SAD Cohorts 2-10 and MAD will be based on safety, tolerability and pharmacokinetic data from preceding cohorts. After all participants have complete Day 8 (SAD) or Day 29 (MAD), a safety review committee (SRC) will determine if the next dose level cohort will be initiated.
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)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Female or male between the ages of 18 and 65 years, inclusive
- •Medically healthy (without significant medical issues, e.g. high blood pressure)
- •Must provide written informed consent
排除标准
- •Ongoing or history of any psychiatric, medical or surgical condition that might jeopardize the participant's safety or interfere with the absorption, distribution or excretion of the study drug
- •Any abnormal ECG findings, laboratory value or physical examination findings
- •Positive ethanol, drug screen or cotinine test
- •Use of systemic prescription medications or over-the-counter (OTC) medication, including multivitamins, and dietary and herbal supplement within 7 days
- •Use of any experimental or investigational device within 30 days
- •Donation or loss of 500 mL or more of blood within 30 weeks and/or donation of plasma within 30 days
研究组 & 干预措施
LIFE-001 Single Ascending Dose Cohorts
LIFE-001
干预措施: LIFE-001 (Drug)
Placebo Single Ascending Dose Cohorts
Placebo
干预措施: Placebo (Drug)
LIFE-001 Multiple Ascending Dose Cohorts
LIFE-001
干预措施: LIFE-001 MAD (Drug)
Placebo Multiple Ascending Dose Cohorts
Placebo
干预措施: Placebo MAD (Drug)
结局指标
主要结局
Adverse events
时间窗: SAD: Predose and Day 1 though Day 22 postdose; MAD: Predose and Day 1 through 56 post initial dose.
Participant and clinician-reported adverse events
Adverse events
时间窗: SAD: Predose and Day 1 though Day 22 postdose; MAD Cohorts 1-4: Predose and Day 1 through 56 post initial dose. MAD Cohort 5-6: Predose and Day 1 through 43 post initial dose.
Participant and clinician-reported adverse events
次要结局
- Plasma concentration(SAD: Predose and Day 1 through 22 postdose; MAD: Predose and Day 1 through 56 post initial dose.)
- Cmax(SAD: Predose and Day 1 through 22 postdose; MAD: Predose and Day 1 through 56 post initial dose.)
- Tmax(SAD: Predose and Day 1 through 22 postdose; MAD: Predose and Day 1 through 56 post initial dose.)
- Plasma concentration(SAD: Predose and Day 1 though Day 22 postdose; MAD Cohorts 1-4: Predose and Day 1 through 56 post initial dose. MAD Cohort 5-6: Predose and Day 1 through 43 post initial dose.)
- Cmax(SAD: Predose and Day 1 though Day 22 postdose; MAD Cohorts 1-4: Predose and Day 1 through 56 post initial dose. MAD Cohort 5-6: Predose and Day 1 through 43 post initial dose.)
- Tmax(SAD: Predose and Day 1 though Day 22 postdose; MAD Cohorts 1-4: Predose and Day 1 through 56 post initial dose. MAD Cohort 5-6: Predose and Day 1 through 43 post initial dose.)