A First-in-human, 3-part Study of MRT-8102 in Healthy Participants and Participants at Cardiovascular Risk With Elevated CRP
NCT ID: NCT07119125
Last Updated: 2025-10-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
100 participants
INTERVENTIONAL
2025-06-27
2026-03-31
Brief Summary
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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
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Detailed Description
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* Learn about the safety and tolerability of single and multiple ascending oral doses of MRT-8102 in healthy adult participants
* Learn about the safety and tolerability of 28-day daily dosing of MRT-8102 in participants at cardiovascular risk with elevated CRP
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
QUADRUPLE
Study Groups
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Part 1: Single Ascending Dose (MRT-8102)
Single Dose of MRT-8102
MRT-8102
Oral capsules
Part 1: Single Ascending Dose (Placebo)
Single Dose of Placebo
Placebo
Oral capsules
Part 2: Multiple Ascending Dose (MRT-8102)
7-day Daily Dose of MRT-8102
MRT-8102
Oral capsules
Part 2: Multiple Ascending Dose (Placebo)
7-day Daily Dose of Placebo
Placebo
Oral capsules
Part 3: elevated CRP (MRT-8102)
28-day Daily Dose of MRT-8102
MRT-8102
Oral capsules
Part 3: elevated CRP (Placebo)
28-day Daily Dose of Placebo
Placebo
Oral capsules
Interventions
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MRT-8102
Oral capsules
Placebo
Oral capsules
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
65 Years
ALL
Yes
Sponsors
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Monte Rosa Therapeutics, Inc
INDUSTRY
Responsible Party
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Locations
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Clinical Pharmacology of Miami, LLC
Miami, Florida, United States
ICON Clinical Research
Lenexa, Kansas, United States
QPS
Springfield, Missouri, United States
Endeavor Clinical Trials
San Antonio, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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MRT-8102-001
Identifier Type: -
Identifier Source: org_study_id
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