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

Phase 1

Recruiting

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

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

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Single Ascending Dose	MRT-6160	Single Ascending Dose of either: MRT-6160 or matching placebo
Single Ascending Dose	Placebo	Single Ascending Dose of either: MRT-6160 or matching placebo
Multiple Ascending Dose	MRT-6160	Multiple Ascending Dose of either: MRT-6160 or matching placebo
Multiple Ascending Dose	Placebo	Multiple Ascending Dose of either: MRT-6160 or matching placebo

Primary Outcome Measures

Name	Time	Method
To evaluate the safety and tolerability of single ascending doses of MRT-6160 in healthy adult subjects	6 weeks	Frequency of adverse events as assessed by the National Cancer Institute - Common Terminology Criteria for Adverse Events Version 5.0
To evaluate the safety and tolerability of multiple ascending doses of MRT-6160 in healthy adult subjects	7.5 weeks	Frequency of adverse events as assessed by the National Cancer Institute - Common Terminology Criteria for Adverse Events Version 5.0

Secondary Outcome Measures

Name	Time	Method
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	Area under the plasma concentration versus time (AUC)

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