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NCT07119125

A First-in-human, 3-part Study of MRT-8102 in Healthy Participants and Participants at Cardiovascular Risk With Elevated CRP

Active, Not Recruiting
PHASE1Ages 18–65InterventionalTreatment
Monte Rosa Therapeutics, Inc
~100 participants
Updated 2026-06-04 on ClinicalTrials.gov
What's tested:MRT-8102Placebo

At a glance

Recruiting sites
0 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To evaluate the safety and tolerability of single doses of MRT-8102 in healthy adult participants
Measured over 15 days
+2 more outcomes measured

Conditions

Healthy Volunteers
Elevated CRP

Explore related trials

Cardiovascular RiskC-reactive protein above reference rangeHealthy Volunteers

NCT07119125

Where you'd take part

This study runs at 4 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Clinical Pharmacology of Miami, LLC

    Miami, Floridano site contact published

  • Endeavor Clinical Trials

    San Antonio, Texasno site contact published

  • ICON Clinical Research

    Lenexa, Kansasno site contact published

  • QPS

    Springfield, Missourino site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

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
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

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

What this trial measures

  • To evaluate the safety and tolerability of single doses of MRT-8102 in healthy adult participants15 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.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 CRP56 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