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MRT-6160

Phase 1

Undisclosed | Small molecule | Other |Monte Rosa Therapeutics, Inc.|Trials Updated: Jul 28, 2025

MRT-6160 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Sep 2024

MRT-6160 target and mechanism

Molecular targetVAV1
Target classProtein
ModalitySmall molecule

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

MRT-6160 clinical trials

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 drug developed by Monte Rosa Therapeutics, Inc. It is a Phase 1 clinical-stage candidate that has been studied in healthy adult volunteers. The specific disease indications being pursued for MRT-6160 have not been disclosed.

What does MRT-6160 target?

MRT-6160 targets VAV1, a protein. VAV1 is a guanine nucleotide exchange factor involved in immune cell signaling. By binding to VAV1, MRT-6160 is designed to modulate its activity. This targeted approach distinguishes it from drugs that act on broader pathways.

Who is developing MRT-6160?

MRT-6160 is being developed by Monte Rosa Therapeutics, Inc., a biotechnology company. The company trades on the Nasdaq under the ticker symbol GLUE. Monte Rosa specializes in small molecule therapeutics, and MRT-6160 is one of its clinical-stage programs.

What phase is MRT-6160 in?

MRT-6160 is in Phase 1 clinical development. It has completed a first-in-human study in healthy subjects. As an investigational drug, it has not been approved by the FDA for any indication. Further clinical testing would be required to establish safety and efficacy.

What clinical trials is MRT-6160 in?

MRT-6160 has been evaluated in a single clinical trial, NCT06597799, titled First-in-human Study of MRT-6160 in Healthy Subjects. This Phase 1 trial enrolled 108 participants in the United States and is now completed. It was randomized, double-blind, and controlled.