Phase 1, First-in-Human, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose, Multiple Ascending Dose, and Food-Effect Study to Assess Safety, Tolerability, PK and PD of MRT-6160 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 2
- 主要终点
- To evaluate the safety and tolerability of single ascending doses of MRT-6160 in healthy adult subjects
研究概览
简要总结
The principal aim of this study is to obtain safety and tolerability data when MRT-6160 is administered orally as single and multiple doses to healthy subjects. This information, together with the pharmacokinetic (PK) data, will help establish the doses and dosing regimen suitable for future studies in patients.
The study drug, MRT-6160, is experimental. This is the first study in which MRT-6160 will be given to humans.
Part 1: Subjects will receive a single oral dose of MRT-6160 or placebo on Day 1
Part 2: Subjects will receive multiple oral doses of MRT-6160 or placebo for 7 consecutive days
详细描述
Detailed Description:
The purpose of this study is to:
Learn about the safety and tolerability of single and multiple ascending oral doses of MRT-6160 in healthy adult subjects
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
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy, adult, male or females 19-65 years of age
- •Non smoker who has not used nicotine and tobacco containing products for at least 3 months prior to start of study
- •Able to swallow oral medications
- •Understands the study procedures in the informed consent form (ICF) and be willing and able to comply with the protocol
排除标准
- •History or presence of clinically significant medical or psychiatric condition or disease that will interfere with adherence to study protocol
- •Underwent surgical intervention or an operation within 4 weeks prior to start of study
- •Has active TB, latent TB, a history of TB, or had close contact with a person with active TB within 8 weeks prior to the first dosing
- •Female subject with a positive pregnancy test or who is lactating
- •Positive urine drug or alcohol screen results
- •Positive COVID-19 results indicating recent or current COVID-19
- •Positive results for human immunodeficiency virus (HIV), hepatitis B or hepatitis C virus or history of resolved hepatitis
- •Participation in another clinical study within 30 days or within 5 half-lives (if known) prior to start of study
研究组 & 干预措施
Single Ascending Dose
Single Ascending Dose of either:
MRT-6160 or matching placebo
干预措施: MRT-6160 (Drug)
Single Ascending Dose
Single Ascending Dose of either:
MRT-6160 or matching placebo
干预措施: Placebo (Drug)
Multiple Ascending Dose
Multiple Ascending Dose of either:
MRT-6160 or matching placebo
干预措施: MRT-6160 (Drug)
Multiple Ascending Dose
Multiple Ascending Dose of either:
MRT-6160 or matching placebo
干预措施: Placebo (Drug)
结局指标
主要结局
To evaluate the safety and tolerability of single ascending doses of MRT-6160 in healthy adult subjects
时间窗: 6 weeks
Frequency of adverse events as assessed by the National Cancer Institute - Common Terminology Criteria for Adverse Events Version 5.0
To evaluate the safety and tolerability of multiple ascending doses of MRT-6160 in healthy adult subjects
时间窗: 7.5 weeks
Frequency of adverse events as assessed by the National Cancer Institute - Common Terminology Criteria for Adverse Events Version 5.0
次要结局
- To evaluate the effects of single dose or multiple doses of MRT-6160 on the heart rate (HR)-corrected QT (QTc) interval by assessing the concentration QT (C-QT) relationship using exposure-response modelling in healthy adult subjects.(6 - 8 weeks)
- To characterize the PK profile of MRT-6160 in plasma after single or multiple doses of MRT-6160 in healthy adult subjects, with and without high fat/high calorie meal(6 - 8 weeks)