A Sequential, Randomized, Double-Blind, Placebo-Controlled, Phase 1 Single and Multiple Ascending Dose Study of LTG-001 Administered Orally of Intravenously to Evaluate the Safety, Tolerability, and Pharmacokinetics in Healthy Male and Female Participants 18 to 55 Years of Age
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 204
- 试验地点
- 1
- 主要终点
- Evaluate the safety and tolerability of single and multiple ascending oral doses, relative bioavailability and food effect of LTG-001 in healthy subjects
研究概览
简要总结
This is a sequential, randomized, double-blind, placebo-controlled Phase 1 single (SAD) and multiple (MAD) ascending dose study to evaluate the safety, tolerability, and pharmacokinetics (PK) of orally or intravenously administered LTG-001 in healthy male and female participants
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female participants aged 18 to 55 years, inclusive, at the time of signing the informed consent.
- •Overtly healthy with no clinically relevant abnormalities based on the medical history, physical examinations, clinical laboratory evaluations, and 12-lead ECG that, in the opinion of the investigator, would affect participant safety.
- •Body mass index (BMI) within the range of 18-32 kg/m2 (inclusive).
排除标准
- •Inability to take oral medications or gastrointestinal abnormalities potentially impacting absorption
- •Clinically significant cardiovascular, hematological, renal, hepatic, pulmonary, endocrine, gastrointestinal, immunological, dermatological, neurological, or psychiatric disease which could interfere with, or the treatment for which might interfere with, the conduct of the study or which would, in the opinion of the investigator, unacceptably increase the participant's risk by participating in the study
- •Past or current history or evidence of alcohol abuse and/or dependence on recreational drug use
- •Donation of over 500 mL blood ≤ 3 months prior to start of participation
- •Has known psychiatric disorders that would interfere with the cooperation with the requirements of the study
- •Participant is under legal custodianship.
研究组 & 干预措施
Placebo
Part A: Single-Ascending dose cohorts; Part B: Multiple-ascending dose cohorts
干预措施: Placebo (Drug)
LTG-001
Part A: Single-Ascending dose cohorts; relative bioavailability; food effect; Part B: Multiple-ascending dose cohorts
干预措施: LTG-001 (Drug)
结局指标
主要结局
Evaluate the safety and tolerability of single and multiple ascending oral doses, relative bioavailability and food effect of LTG-001 in healthy subjects
时间窗: Up to 10 days of dosing
Incidence, severity, seriousness, and causality of treatment-emergent adverse events (TEAEs)
Absolute Bioavailability of LTG-001 Following Oral and Intravenous Administration
时间窗: from admission to completion in the study (35 days)
Absolute bioavailability of LTG-001 will be assessed by comparing systemic exposure following a single oral tablet dose and a single intravenous dose.
Safety and Tolerability of Intravenous LTG-001
时间窗: From first intravenous dose through end of study (up to 14 days following intravenous dosing)
Safety and tolerability of intravenous LTG-001 will be assessed by the number of participants with treatment-emergent adverse events (TEAEs), changes in clinical laboratory parameters, vital signs, electrocardiograms (ECGs), physical examination findings, and infusion site reactions following intravenous administration.
次要结局
- To further characterize the PK of LTG-001 in healthy participants(Up to 10 days of dosing)