A Phase 1, Randomized, Double-Blind, Placebo-Controlled Single and Multiple Dose Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MRT-8102 in Healthy Participants and in Participants at Cardiovascular Risk With Elevated CRP
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 8
- 主要终点
- To evaluate the safety and tolerability of single doses of MRT-8102 in healthy adult participants
研究概览
简要总结
The principal aim of this study is to obtain safety and tolerability data when MRT-8102 is administered orally as single and multiple doses to healthy participants and participants at cardiovascular risk with elevated CRP. This information, together with the pharmacokinetic (PK) data, will help establish the dose and dosing regimen suitable for future studies.
The study drug, MRT-8102, is experimental. This is the first study in which MRT-8102 will be given to humans.
Part 1: Healthy participants will receive a single oral dose of MRT-8102 or placebo on Day 1
Part 2: Healthy participants will receive multiple oral doses of MRT-8102 or placebo for 7 consecutive days
Part 3: Participants at cardiovascular risk with elevated CRP will receive multiple oral doses of MRT-8102 or placebo for 28 consecutive days
详细描述
The purpose of this study is to:
- Learn about the safety and tolerability of single and multiple ascending oral doses of MRT-8102 in healthy adult participants
- Learn about the safety and tolerability of 28-day daily dosing of MRT-8102 in participants at cardiovascular risk with elevated CRP
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Eligibility Criteria:
- •Inclusion Criteria (all parts)
- •Healthy, adult, male or females 18-65 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
- •Abstain from caffeine- and methylxanthine-containing beverages or food
- •Parts 3: Inclusion Criteria
- •Elevated CRP value ≥3.0 mg/L at the time of screening
- •Evidence of cardiovascular risk factors
- •No signs or symptoms of acute disease
- •No ECG finding of clinical significance
排除标准
- •(All Parts)
- •History or presence of clinically significant medical or psychiatric condition or disease
- •Underwent surgical intervention or an operation withing 6 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
- •Pregnant, breastfeeding, or planning a pregnancy or fathering a child during the study or within 3 months after the last study drug administration.
- •Positive urine drug or alcohol screen results
- •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-live (if known) prior to start of study
- •Currently receiving other immunomodulators
- •History of immunodeficiency, chronic inflammatory and chronic inflammation
研究组 & 干预措施
Part 1: Single Ascending Dose (Placebo)
Single Dose of Placebo
干预措施: Placebo (Drug)
Part 2: Multiple Ascending Dose (Placebo)
7-day Daily Dose of Placebo
干预措施: Placebo (Drug)
Part 1: Single Ascending Dose (MRT-8102)
Single Dose of MRT-8102
干预措施: MRT-8102 (Drug)
Part 2: Multiple Ascending Dose (MRT-8102)
7-day Daily Dose of MRT-8102
干预措施: MRT-8102 (Drug)
Part 3: elevated CRP (MRT-8102)
28-day Daily Dose of MRT-8102
干预措施: MRT-8102 (Drug)
Part 3: elevated CRP (Placebo)
28-day Daily Dose of Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
To evaluate the safety and tolerability of single doses of MRT-8102 in healthy adult participants
时间窗: 15 days
Incidence of treatment-emergent adverse events by type severity seriousness and relationship to treatment and changes from baseline in safety-related clinical lab parameter, vital signs 12-lead ECGs and PEs
To evaluate the safety and tolerability of multiple ascending doses of MRT-8102 in healthy adult participants.
时间窗: 21 days
Incidence of treatment-emergent adverse events by type severity seriousness and relationship to treatment and changes from baseline in safety-related clinical lab parameter, vital signs 12-lead ECGs and PEs
To evaluate the safety and tolerability of 28-day daily dosing of MRT-8102 in participants at cardiovascular risk with elevated CRP
时间窗: 56 days
Incidence of treatment-emergent adverse events by type severity seriousness and relationship to treatment and changes from baseline in safety-related clinical lab parameter, vital signs 12-lead ECGs and PEs
次要结局
- Characterize the PK profile (peak plasma concentration) of MRT-8102 in plasma after multiple doses of MRT-8102 in healthy adult participants(Up to 14 days)
- Characterize the PK Profile (plasma concentration versus time) of MRT-8102 when administered daily to participants at cardiovascular risk with elevated CRP(Up to 35 days)
- Assess the effect of a high-fat/high-calorie meal on the PK (peak plasma concentration) of MRT-8102 02 in healthy adult participants(Up to 8 days)
- Characterize the PK profile (plasma concentration versus time) of MRT-8102 in plasma after multiple doses of MRT-8102 in healthy adult participants(Up to 14 days)
- Characterize the PK Profile (peak plasma concentration) of MRT-8102 when administered daily to participants at cardiovascular risk with elevated CRP(Up to 35 days)
- Characterize the PK Profile (peak plasma concentration) of MRT-8102 after single doses of MRT-8102 in healthy adult participants(Up to 8 days)
- Characterize the PK Profile (plasma concentration versus time) of MRT-8102 after single doses of MRT-8102 in healthy adult participants(Up to 8 days)
- Assess the effect of a high-fat/high-calorie meal on the PK (plasma concentration versus time) of MRT-8102 02 in healthy adult participants(Up to 8 days)
- Assess the impact of MRT-8102 on serum concentration of CRP(Up to 35 days)