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

NCT06597799 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2025-07-28

No results posted yet for this study

Summary

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

Conditions

  • Healthy Volunteers

Interventions

DRUG

MRT-6160

Orally administered tablets or capsules of MRT-6160

DRUG

Placebo

Orally administered tablets or capsules of placebo

Sponsors & Collaborators

  • Monte Rosa Therapeutics, Inc

    lead INDUSTRY

Principal Investigators

  • CRO · Celerion

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
19 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-08-07
Primary Completion
2025-04-10
Completion
2025-04-10
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06597799 on ClinicalTrials.gov