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

NCT07119125 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-10-10

No results posted yet for this study

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

Interventions

DRUG

MRT-8102

Oral capsules

DRUG

Placebo

Oral capsules

Sponsors & Collaborators

  • Monte Rosa Therapeutics, Inc

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-06-27
Primary Completion
2026-01-31
Completion
2026-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07119125 on ClinicalTrials.gov