MRT-6160 for Healthy Subjects

Recruiting in Palo Alto (17 mi)

Overseen ByCRO

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Monte Rosa Therapeutics, Inc

No Placebo Group

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

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.

Exclusion Criteria

I am currently pregnant or breastfeeding.

I have been exposed to or have had tuberculosis.

Participant Groups

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.

2Treatment groups

Experimental Treatment

Group I: Single Ascending DoseExperimental Treatment2 Interventions

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

Group II: Multiple Ascending DoseExperimental Treatment2 Interventions

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