Actively Recruiting
A First-in-human, 3-part Study of MRT-8102 in Healthy Participants and Participants at Cardiovascular Risk With Elevated CRP
Led by Monte Rosa Therapeutics, Inc · Updated on 2025-10-10
100
Participants Needed
4
Research Sites
35 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
A First-in-human, 3-part Study of MRT-8102 in Healthy Participants and Participants at Cardiovascular Risk With Elevated CRP
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy adults aged 18 to 65 years
- Non-smokers who have not used nicotine or tobacco products for at least 3 months before the study
- Able to swallow oral medications
- Abstain from caffeine- and methylxanthine-containing beverages or foods
- For Part 3: Elevated CRP value of 3.0 mg/L or higher at screening
- For Part 3: Evidence of cardiovascular risk factors
- For Part 3: No signs or symptoms of acute disease
- For Part 3: No clinically significant ECG findings
You will not qualify if you...
- History or presence of clinically significant medical or psychiatric conditions or diseases
- Surgery or operation within 6 weeks before the study starts
- Active, latent, or history of tuberculosis, or close contact with active TB within 8 weeks before dosing
- Pregnant, breastfeeding, or planning pregnancy or fathering a child during the study or within 3 months after last drug dose
- Positive urine drug or alcohol screen
- Positive for HIV, hepatitis B or C, or history of resolved hepatitis
- Participation in another clinical study within 30 days or within 5 half-lives of a drug before the study
- Currently receiving other immunomodulators
- History of immunodeficiency, chronic inflammation, or chronic inflammatory conditions
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 4 locations
1
Clinical Pharmacology of Miami, LLC
Miami, Florida, United States, 33172
Actively Recruiting
2
ICON Clinical Research
Lenexa, Kansas, United States, 66219
Actively Recruiting
3
QPS
Springfield, Missouri, United States, 65807
Actively Recruiting
4
Endeavor Clinical Trials
San Antonio, Texas, United States, 78240
Actively Recruiting
Research Team
M
Monte Rosa Therapeutics Inc. Sponsor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
6
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