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

Monte Rosa Therapeutics, Inc108 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

108

Conditions

Healthy Volunteers

Interventions

MRT-6160DRUG

Orally administered tablets or capsules of MRT-6160

PlaceboDRUG

Orally administered tablets or capsules of placebo

Eligibility

Sex: ALLMin age: 19 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 be willing and able to comply with the protocol Exclusion Criteria: * 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

Locations (2)

Celerion, Inc.

Tempe, Arizona, United States

Celerion

Lincoln, Nebraska, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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