NCT06597799

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

Phase 1, First-in-Human, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose, Multiple Ascending Dose, and Food-Effect Study to Assess Safety, Tolerability, PK and PD of MRT-6160 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 108 (actual)
• Sponsor: Monte Rosa Therapeutics, Inc · Industry
• Sex: All
• Age: 19 Years – 65 Years
• Healthy volunteers: Accepted

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

Detailed description

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

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	MRT-6160	Orally administered tablets or capsules of MRT-6160
DRUG	Placebo	Orally administered tablets or capsules of placebo

Timeline

• Start date: 2024-08-07
• Primary completion: 2025-04-10
• Completion: 2025-04-10
• First posted: 2024-09-19
• Last updated: 2025-07-28

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study