A Sequential, Randomized, Double-Blind, Placebo-Controlled, Phase 1, Single and Multiple Ascending Dose Study of LTG-305 Administered Orally to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Healthy Male and Female Participants 18 to 55 Years of Age
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
- To evaluate the safety and tolerability of single and multiple ascending oral doses of LTG-305 in healthy participants.
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) and Pharmacodynamics of orally administered LTG-305 in healthy male and female participants. The study will also include a randomized, double-blind, placebo-controlled within-participant crossover evaluation of pain tolerance during a cold pressor test in healthy male participants 18-55 years of age.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 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 for SAD and MAD only. For Cold Pressor male participants 18 to 55 years.
- •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
- •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
- •Participant is under legal custodianship.
研究组 & 干预措施
LTG-305
干预措施: LTG-305 (Drug)
Placebo
干预措施: LTG-305 (Drug)
结局指标
主要结局
To evaluate the safety and tolerability of single and multiple ascending oral doses of LTG-305 in healthy participants.
时间窗: Up to 7 or 10 days of dosing
Incidence, severity, seriousness, and causality of treatment-emergent adverse events (TEAEs)
To evaluate the pharmacodynamics of LTG-305 in healthy male participants.
时间窗: 0-24 hrs, 1-12 hours
Change from baseline at various individual time points and at various intervals for time to reach PDT and time to reach PTT, for each dose of LTG-305 vs. placebo. Time to reach PDT and time to reach PTT at various individual time points and at various intervals for each dose of LTG-305 vs. placebo. Area above the Curve (AAC) calculated via NPRS scores vs. time, for each dose of LTG-305 vs. placebo Exposure response
次要结局
未报告次要终点