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Completed

NCT Number: NCT06597799

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

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

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Key information

Conditions

Healthy Volunteers

Age range

19 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Celerion, Inc., Tempe, Arizona, United States

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About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 3 months prior to start of study
  • Able to swallow oral medications
  • Understands the study procedures in the informed consent form (ICF) and be willing and able to comply with the protocol

Exclusion criteria

  • History or presence of clinically significant medical or psychiatric condition or disease that will interfere with adherence to study protocol
  • Underwent surgical intervention or an operation within 4 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
  • 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 C virus or history of resolved hepatitis
  • Participation in another clinical study within 30 days or within 5 half-lives (if known) prior to start of study

Treatment and study plan

MRT-6160

Drug

Orally administered tablets or capsules of MRT-6160

Placebo

Drug

Orally administered tablets or capsules of placebo

Primary outcomes

  1. To evaluate the safety and tolerability of single ascending doses of MRT-6160 in healthy adult subjects

    Time frame: 6 weeks

    Frequency of adverse events as assessed by the National Cancer Institute - Common Terminology Criteria for Adverse Events Version 5.0

  2. To evaluate the safety and tolerability of multiple ascending doses of MRT-6160 in healthy adult subjects

    Time frame: 7.5 weeks

    Frequency of adverse events as assessed by the National Cancer Institute - Common Terminology Criteria for Adverse Events Version 5.0

Secondary outcomes

  1. To evaluate the effects of single dose or multiple doses of MRT-6160 on the heart rate (HR)-corrected QT (QTc) interval by assessing the concentration QT (C-QT) relationship using exposure-response modelling in healthy adult subjects.

    Time frame: 6 - 8 weeks

  2. To characterize the PK profile of MRT-6160 in plasma after single or multiple doses of MRT-6160 in healthy adult subjects, with and without high fat/high calorie meal

    Time frame: 6 - 8 weeks

    Peak plasma Concentration (Cmax)

  3. To characterize the PK profile of MRT-6160 in plasma after single or multiple doses of MRT-6160 in healthy adult subjects, with and without high fat/high calorie meal

    Time frame: 6 - 8 weeks

    Area under the plasma concentration versus time (AUC)

Sponsors and collaborators

Lead sponsor

Monte Rosa Therapeutics, Inc

Industry

Registry information

Official study title

Phase 1, First-in-Human, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose, Multiple Ascending Dose, and Food-Effect Study to Assess Safety, Tolerability, PK and PD of MRT-6160 in Healthy Subjects

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
Jul 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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