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RECRUITING
NCT07119125
PHASE1

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

Sponsor: Monte Rosa Therapeutics, Inc

View on ClinicalTrials.gov

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

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2025-06-27

Completion Date

2026-03

Last Updated

2025-10-10

Healthy Volunteers

Yes

Interventions

DRUG

MRT-8102

Oral capsules

DRUG

Placebo

Oral capsules

Locations (4)

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