RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2025-06-27
Study Completion:2026-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07119125

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Monte Rosa Therapeutics Inc. Sponsor
CONTACT
617-949-2643
Clinicaltrials@monterosatx.com

Study Locations (Sites)

ICON Clinical Research
Lenexa, Kansas, 66219
United States

Collaborators and Investigators

Sponsor: Monte Rosa Therapeutics, Inc

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-27
Study Completion Date2026-03

Study Record Updates

Study Start Date2025-06-27
Study Completion Date2026-03

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Healthy Volunteers
  • Elevated CRP