First-in-human, 3-part MRT-8102 in healthy adults and adults with elevated CRP
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
This trial will test oral MRT-8102 in healthy adults and in adults at cardiovascular risk with high CRP to see if it is safe and how the body handles it.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Monte Rosa Therapeutics, Inc Industry-sponsored |
| Locations | 4 sites (Miami, Florida and 3 other locations) |
| Trial ID | NCT07119125 on ClinicalTrials.gov |
What this trial studies
This first-in-human, randomized, placebo-controlled Phase 1 study gives single and multiple ascending oral doses of MRT-8102 to healthy adults (parts 1 and 2) and multiple daily doses for 28 days to adults with elevated CRP and cardiovascular risk (part 3). Safety, tolerability, and pharmacokinetics will be collected to define appropriate doses for later trials. Participants will be non-smokers aged 18–65, and part 3 requires CRP ≥3.0 mg/L and evidence of cardiovascular risk factors. The study uses placebo controls and escalating dose cohorts to monitor adverse events and drug exposure.
Who should consider this trial
Good fit: Ideal candidates are non-smoking adults 18–65 who are either healthy volunteers or adults with elevated CRP (≥3.0 mg/L) and cardiovascular risk factors, and who meet the study's other inclusion/exclusion criteria.
Not a fit: People with significant medical or psychiatric conditions, recent surgery, active or recent TB exposure, smokers, or those who are pregnant or breastfeeding are excluded and are unlikely to benefit from this study.
Why it matters
Potential benefit: If MRT-8102 is safe and well tolerated, it could become a new oral option to target inflammation in people at cardiovascular risk.
How similar studies have performed: This is the first human study of MRT-8102 so there are no human data for this molecule, and while other anti-inflammatory approaches for cardiovascular risk have shown mixed but sometimes promising results, MRT-8102 is untested in people.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Miami, Florida and 3 other locations
- Clinical Pharmacology of Miami, LLC — Miami, Florida, United States (Recruiting)
- ICON Clinical Research — Lenexa, Kansas, United States (Recruiting)
- Qps — Springfield, Missouri, United States (Recruiting)
- Endeavor Clinical Trials — San Antonio, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Monte Rosa Therapeutics Inc. Sponsor
- Email: Clinicaltrials@monterosatx.com
- Phone: 617-949-2643
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.