A Phase 1 interventional study of MRT-6160 and Placebo in Healthy Volunteers, sponsored by Monte Rosa Therapeutics, Inc. Completed at 2 sites in United States. Open to participants aged 19 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-28.
Sponsored by Monte Rosa Therapeutics, Inc · Phase 1, Interventional, and Treatment
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
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
Monte Rosa Therapeutics, Inc is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Single Ascending Dose of either: MRT-6160 or matching placebo
Drug: MRT-6160 · Drug: Placebo
Multiple Ascending Dose of either: MRT-6160 or matching placebo
Drug: MRT-6160 · Drug: Placebo
Orally administered tablets or capsules of MRT-6160
Orally administered tablets or capsules of placebo
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
Time frame: 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
Time frame: 7.5 weeks
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
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)
Time frame: 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)
Time frame: 6 - 8 weeks
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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Monte Rosa Therapeutics, Inc