MRT-6160 for Healthy Subjects

Overseen By Sponsor

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Monte Rosa Therapeutics, Inc

Disqualifiers: TB, HIV, Hepatitis, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

76 Participants Needed

Trial Summary

What is the purpose of this trial?

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

Research Team

CRO

Principal Investigator

Celerion

Eligibility Criteria

This trial is for healthy individuals who can participate in a study to test the safety and tolerability of a new drug, MRT-6160. The details about specific inclusion or exclusion criteria are not provided.

Inclusion Criteria

I am a healthy adult between 19 and 65 years old.

I have not smoked or used nicotine products for at least 3 months.

Understands the study procedures in the informed consent form (ICF) and be willing and able to comply with the protocol

Exclusion Criteria

Positive COVID-19 results indicating recent or current COVID-19

I am currently pregnant or breastfeeding.

I have been exposed to or have had tuberculosis.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Single Ascending Dose

Subjects receive a single oral dose of MRT-6160 or placebo on Day 1

1 day

1 visit (in-person)

Multiple Ascending Dose

Subjects receive multiple oral doses of MRT-6160 or placebo for 7 consecutive days

1 week

7 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6-8 weeks

Treatment Details

Interventions

• MRT-6160

Trial Overview The trial is testing MRT-6160, an experimental drug given orally. Participants will either receive this new drug or a placebo (a substance with no active drug). It's divided into two parts: one-time dose and daily doses over seven days to gather safety data and understand how the body processes it.

Participant Groups

Group I: Single Ascending Dose Experimental Treatment 2 Interventions

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

Group II: Multiple Ascending Dose Experimental Treatment 2 Interventions

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

Who Is Running the Clinical Trial?

Monte Rosa Therapeutics, Inc

Lead Sponsor

Trials

2

Recruited

250+