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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-07

Study Completion Date

2025-04-10

Brief Summary

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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

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Detailed Description

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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

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Sequential Ascending Doses, Multiple Ascending Doses

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Single Ascending Dose

Single Ascending Dose of either:

MRT-6160 or matching placebo

Group Type EXPERIMENTAL

MRT-6160

Intervention Type DRUG

Orally administered tablets or capsules of MRT-6160

Placebo

Intervention Type DRUG

Orally administered tablets or capsules of placebo

Multiple Ascending Dose

Multiple Ascending Dose of either:

MRT-6160 or matching placebo

Group Type EXPERIMENTAL

MRT-6160

Intervention Type DRUG

Orally administered tablets or capsules of MRT-6160

Placebo

Intervention Type DRUG

Orally administered tablets or capsules of placebo

Interventions

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MRT-6160

Orally administered tablets or capsules of MRT-6160

Intervention Type DRUG

Placebo

Orally administered tablets or capsules of placebo

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes