First-in-human Study of MRT-6160 in Healthy Subjects

Last updated: September 12, 2024
Sponsor: Monte Rosa Therapeutics, Inc
Overall Status: Active - Recruiting

Phase

1

Condition

Healthy Volunteers

Treatment

MRT-6160

Placebo

Clinical Study ID

NCT06597799
MRT-6160-001
  • Ages 19-65
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The principal aim of this study is to obtain safety and tolerability data when MRT-6160 is administered orally as single and multiple doses to healthy subjects. This information, together with the pharmacokinetic (PK) data, will help establish the doses and dosing regimen suitable for future studies in patients.

The study drug, MRT-6160, is experimental. This is the first study in which MRT-6160 will be given to humans.

Part 1: Subjects will receive a single oral dose of MRT-6160 or placebo on Day 1

Part 2: Subjects will receive multiple oral doses of MRT-6160 or placebo for 7 consecutive days

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Healthy, adult, male or females 19-65 years of age

  • Non smoker who has not used nicotine and tobacco containing products for at least 3months prior to start of study

  • Able to swallow oral medications

  • Understands the study procedures in the informed consent form (ICF) and be willingand able to comply with the protocol

Exclusion

Exclusion Criteria:

  • History or presence of clinically significant medical or psychiatric condition ordisease that will interfere with adherence to study protocol

  • Underwent surgical intervention or an operation within 4 weeks prior to start ofstudy

  • Has active TB, latent TB, a history of TB, or had close contact with a person withactive TB within 8 weeks prior to the first dosing

  • Female subject with a positive pregnancy test or who is lactating

  • Positive urine drug or alcohol screen results

  • Positive COVID-19 results indicating recent or current COVID-19

  • Positive results for human immunodeficiency virus (HIV), hepatitis B or hepatitis Cvirus or history of resolved hepatitis

  • Participation in another clinical study within 30 days or within 5 half-lives (ifknown) prior to start of study

Study Design

Total Participants: 76
Treatment Group(s): 2
Primary Treatment: MRT-6160
Phase: 1
Study Start date:
August 07, 2024
Estimated Completion Date:
January 31, 2025

Study Description

Detailed Description:

The purpose of this study is to:

Learn about the safety and tolerability of single and multiple ascending oral doses of MRT-6160 in healthy adult subjects

Connect with a study center

  • Celerion

    Lincoln, Nebraska 68502
    United States

    Active - Recruiting

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