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

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

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

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: MRT-6160; Drug: Placebo

Detailed 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

• Study Type: Interventional
• Enrollment (Actual): 108
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tempe, Arizona, United States, 85283
      • Celerion, Inc.
  • Nebraska
    • Lincoln, Nebraska, United States, 68502
      • Celerion

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single Ascending Dose; Single Ascending Dose of either: MRT-6160 or matching placebo	Drug: MRT-6160; Orally administered tablets or capsules of MRT-6160; Drug: Placebo; Orally administered tablets or capsules of placebo
Experimental: Multiple Ascending Dose; Multiple Ascending Dose of either: MRT-6160 or matching placebo	Drug: MRT-6160; Orally administered tablets or capsules of MRT-6160; Drug: Placebo; Orally administered tablets or capsules of placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the safety and tolerability of single ascending doses of MRT-6160 in healthy adult subjects	Frequency of adverse events as assessed by the National Cancer Institute - Common Terminology Criteria for Adverse Events Version 5.0	6 weeks
To evaluate the safety and tolerability of multiple ascending doses of MRT-6160 in healthy adult subjects	Frequency of adverse events as assessed by the National Cancer Institute - Common Terminology Criteria for Adverse Events Version 5.0	7.5 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.		6 - 8 weeks
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	Peak plasma Concentration (Cmax)	6 - 8 weeks
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	Area under the plasma concentration versus time (AUC)	6 - 8 weeks

Collaborators and Investigators

• Sponsor: Monte Rosa Therapeutics, Inc
• Investigators: Principal Investigator: CRO, Celerion

Study record dates

Study Major Dates

• Study Start (Actual): August 7, 2024
• Primary Completion (Actual): April 10, 2025
• Study Completion (Actual): April 10, 2025

Study Registration Dates

• First Submitted: August 2, 2024
• First Submitted That Met QC Criteria: September 12, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): July 28, 2025
• Last Update Submitted That Met QC Criteria: July 23, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Healthy Volunteers; SAD; MAD; Single Ascending Dose; Multiple Ascending Dose; MRT; MRT-6160; MRT-6160-001; Monte Rosa Therapeutics
• Other Study ID Numbers: MRT-6160-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No