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MRT-6160

Phase 1

Healthy Volunteers | Small molecule | Other |Monte Rosa Therapeutics, Inc.|Last Updated: Jul 28, 2025

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment108

FDA Designations

No designations recorded

Clinical trial landscape

MRT-6160 · 1 trial · 1 indication

Phase 1 1
NCT06597799First-in-human Study of MRT-6160 in Healthy SubjectsHealthy Volunteers
COMPLETED108 Analytics
PHASE1COMPLETED
First-in-human Study of MRT-6160 in Healthy Subjects
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Study Endpoints

Primary Endpoints

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

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

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

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

Secondary Endpoints

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
6 - 8 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Single Ascending DoseEXPERIMENTALSingle Ascending Dose of either: MRT-6160 or matching placebo
Multiple Ascending DoseEXPERIMENTALMultiple Ascending Dose of either: MRT-6160 or matching placebo

Interventions

NameTypeDescription
MRT-6160DRUGOrally administered tablets or capsules of MRT-6160
PlaceboDRUGOrally administered tablets or capsules of placebo
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Eligibility Criteria

Age Range19 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites2

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 ...

Countries:United States
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Frequently asked questions about MRT-6160

What is MRT-6160?

MRT-6160 is an investigational small molecule being developed by Monte Rosa Therapeutics, Inc. (NASDAQ: GLUE). It is currently in Phase 1 clinical development, having been studied in a first-in-human trial in healthy volunteers. The drug is not approved and remains under clinical investigation.

What is MRT-6160 used for?

MRT-6160 is being studied for use in healthy volunteers as part of a first-in-human clinical trial. The study is designed to evaluate the drug's safety, tolerability, and pharmacokinetics in this population. It is not yet approved for any medical condition and is in early-stage clinical development.

Who makes MRT-6160?

MRT-6160 is developed by Monte Rosa Therapeutics, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol GLUE. The company is conducting clinical research on this investigational small molecule, which is currently in Phase 1 development.

What phase is MRT-6160 in?

MRT-6160 is in Phase 1 clinical development. A first-in-human study in healthy volunteers has been completed. The drug is investigational and has not received FDA approval. It remains in early-stage clinical testing.

What clinical trials is MRT-6160 in?

MRT-6160 has one completed Phase 1 clinical trial, identified as NCT06597799, titled "First-in-human Study of MRT-6160 in Healthy Subjects." This randomized, double-blind, controlled study enrolled 108 participants in the United States and included healthy volunteers aged 19 years and older.

Is MRT-6160 the same as any other drug?

No alternative names for MRT-6160 have been disclosed. The drug is identified solely by its code name MRT-6160 in clinical trial records and is developed by Monte Rosa Therapeutics. No other designations or brand names are currently associated with this investigational agent.