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

NCT07119125 | Recruiting Phase 1 FDA Drug

• 1 other identifier: MRT-8102-001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 4

Brief 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

Conditions

Healthy Volunteers; Elevated CRP

Keywords

MRT-8102; MRT-8102-001; MRT; Monte Rosa Therapeutics; Healthy Volunteers; Single Ascending Dose; Multiple Ascending Dose; SAD; MAD; CRP; Cardiovascular Risk

Outcome Measures

Primary Outcomes (3)

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

  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

  15 days

• To evaluate the safety and tolerability of multiple ascending doses of MRT-8102 in healthy adult participants.

  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

  21 days

• To evaluate the safety and tolerability of 28-day daily dosing of MRT-8102 in participants at cardiovascular risk with elevated CRP

  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

  56 days

Secondary Outcomes (9)

• Characterize the PK Profile (peak plasma concentration) of MRT-8102 after single doses of MRT-8102 in healthy adult participants

  Up to 8 days

• Characterize the PK Profile (plasma concentration versus time) of MRT-8102 after single doses of MRT-8102 in healthy adult participants

  Up to 8 days

• Assess the effect of a high-fat/high-calorie meal on the PK (peak plasma concentration) of MRT-8102 02 in healthy adult participants

  Up to 8 days

• Assess the effect of a high-fat/high-calorie meal on the PK (plasma concentration versus time) of MRT-8102 02 in healthy adult participants

  Up to 8 days

• Characterize the PK profile (peak plasma concentration) of MRT-8102 in plasma after multiple doses of MRT-8102 in healthy adult participants

  Up to 14 days

Study Arms (6)

Part 1: Single Ascending Dose (MRT-8102)

EXPERIMENTAL

Single Dose of MRT-8102

Drug: MRT-8102

Part 1: Single Ascending Dose (Placebo)

PLACEBO COMPARATOR

Single Dose of Placebo

Drug: Placebo

Part 2: Multiple Ascending Dose (MRT-8102)

EXPERIMENTAL

7-day Daily Dose of MRT-8102

Drug: MRT-8102

Part 2: Multiple Ascending Dose (Placebo)

PLACEBO COMPARATOR

7-day Daily Dose of Placebo

Drug: Placebo

Part 3: elevated CRP (MRT-8102)

EXPERIMENTAL

28-day Daily Dose of MRT-8102

Drug: MRT-8102

Part 3: elevated CRP (Placebo)

PLACEBO COMPARATOR

28-day Daily Dose of Placebo

Drug: Placebo

Interventions

MRT-8102 DRUG

Oral capsules

Part 1: Single Ascending Dose (MRT-8102); Part 2: Multiple Ascending Dose (MRT-8102); Part 3: elevated CRP (MRT-8102)

Placebo DRUG

Oral capsules

Part 1: Single Ascending Dose (Placebo); Part 2: Multiple Ascending Dose (Placebo); Part 3: elevated CRP (Placebo)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Monte Rosa Therapeutics, Inc: lead

Study Sites (4)

Clinical Pharmacology of Miami, LLC

Miami, Florida, 33172, United States

RECRUITING

ICON Clinical Research

Lenexa, Kansas, 66219, United States

RECRUITING

QPS

Springfield, Missouri, 65807, United States

RECRUITING

Endeavor Clinical Trials

San Antonio, Texas, 78240, United States

RECRUITING

Central Study Contacts

Monte Rosa Therapeutics Inc. Sponsor

CONTACT

617-949-2643; Clinicaltrials@monterosatx.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2025
• First Posted: August 12, 2025
• Study Start: June 27, 2025
• Primary Completion: January 1, 2026
• Study Completion: March 1, 2026
• Last Updated: October 10, 2025

Record last verified: 2025-10

Locations

US (4)