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MRT-6160

Phase 1

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment108
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06597799First-in-human Study of MRT-6160 in Healthy SubjectsPHASE1 COMPLETED 108 — — Aug 7, 2024Apr 10, 2025Jul 28, 20252 United States
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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 — 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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