A First-in-human, 3-part Study of MRT-8102 in Healthy Participants and Participants at Cardiovascular Risk 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
Monte Rosa Therapeutics, Inc
100 participants
Jun 27, 2025
INTERVENTIONAL
Conditions
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
Eligibility
Inclusion Criteria9
- Eligibility Criteria:
- 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 Criteria9
- 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
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Interventions
Oral capsules
Oral capsules
Locations(4)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07119125