A First-in-human, 3-part Study of MRT-8102 in Healthy Participants and Participants at Cardiovasc… (NCT07119125) | Clinical Trial Compass
Active — Not RecruitingPhase 1
A First-in-human, 3-part Study of MRT-8102 in Healthy Participants and Participants at Cardiovascular Risk With Elevated CRP
United States100 participantsStarted 2025-06-27
Plain-language summary
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
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Exclusion Criteria (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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To evaluate the safety and tolerability of single doses of MRT-8102 in healthy adult participants
Timeframe: 15 days
2
To evaluate the safety and tolerability of multiple ascending doses of MRT-8102 in healthy adult participants.
Timeframe: 21 days
3
To evaluate the safety and tolerability of 28-day daily dosing of MRT-8102 in participants at cardiovascular risk with elevated CRP