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

NCT06597799 | Completed Phase 1 FDA Drug

• 1 other identifier: MRT-6160-001
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

MRT-6160; MRT-6160-001; MRT; Monte Rosa Therapeutics; Healthy Volunteers; Single Ascending Dose; Multiple Ascending Dose; SAD; MAD

Outcome Measures

Primary Outcomes (2)

• 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

  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

  7.5 weeks

Secondary Outcomes (3)

• 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

• 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

Study Arms (2)

Single Ascending Dose

EXPERIMENTAL

Single Ascending Dose of either: MRT-6160 or matching placebo

Drug: MRT-6160; Drug: Placebo

Multiple Ascending Dose

EXPERIMENTAL

Multiple Ascending Dose of either: MRT-6160 or matching placebo

Drug: MRT-6160; Drug: Placebo

Interventions

MRT-6160 DRUG

Orally administered tablets or capsules of MRT-6160

Multiple Ascending Dose; Single Ascending Dose

Placebo DRUG

Orally administered tablets or capsules of placebo

Multiple Ascending Dose; Single Ascending Dose

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 be willing and able to comply with the protocol

You may not qualify if:

• History or presence of clinically significant medical or psychiatric condition or disease that will interfere with adherence to study protocol
• Underwent surgical intervention or an operation within 4 weeks prior to start of study
• Has active TB, latent TB, a history of TB, or had close contact with a person with active TB within 8 weeks prior to the first dosing
• Female subject with a positive pregnancy test or who is lactating
• Positive urine drug or alcohol screen results
• Positive COVID-19 results indicating recent or current COVID-19
• Positive results for human immunodeficiency virus (HIV), hepatitis B or hepatitis C virus or history of resolved hepatitis
• Participation in another clinical study within 30 days or within 5 half-lives (if known) prior to start of study

Sponsors & Collaborators

• Monte Rosa Therapeutics, Inc: lead

Study Sites (2)

Celerion, Inc.

Tempe, Arizona, 85283, United States

Location

Celerion

Lincoln, Nebraska, 68502, United States

Location

Study Officials

• CRO

  Celerion

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Sequential Ascending Doses, Multiple Ascending Doses

Study Record Dates

• First Submitted: August 2, 2024
• First Posted: September 19, 2024
• Study Start: August 7, 2024
• Primary Completion: April 10, 2025
• Study Completion: April 10, 2025
• Last Updated: July 28, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)