MRT-6160 for Healthy Subjects

No longer recruiting at 1 trial location

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an experimental drug called MRT-6160 to assess its safety and how the body processes it. The trial has two parts: one involves a single dose, and the other involves multiple doses over a week. The goal is to determine safe dosage levels for future trials with patients. The study seeks healthy adults who do not smoke and can easily take oral medication. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. However, since the study is for healthy subjects, it's likely that participants should not be on any regular medications. Please check with the study team for specific guidance.

Is there any evidence suggesting that MRT-6160 is likely to be safe for humans?

Research on MRT-6160 remains in the early stages, so limited safety information is available. This trial marks the first time MRT-6160 is tested in humans. The study aims to assess how well participants tolerate the drug when taken orally in single or multiple doses.

As this is the initial human trial, no previous human data exists. However, the primary goal of this early-phase trial is to gather safety information. Researchers will closely monitor for any side effects and observe how the drug affects the body.

In such trials, safety is the top priority, and participants receive close monitoring for any reactions. Although specific safety data for MRT-6160 is not yet available, this study will help determine if the drug is well-tolerated and identify safe doses for future research. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about MRT-6160 because it offers a potentially new approach to treatment through its unique mechanism. Unlike other treatments that might work by targeting symptoms directly, MRT-6160 is designed to target underlying processes in a novel way, which could lead to more effective management of the condition. This investigational drug could provide a faster onset of action or improved efficacy compared to existing therapies, making it a promising candidate for future therapeutic options. Additionally, its formulation as either a Single Ascending Dose or a Multiple Ascending Dose allows researchers to explore different dosing strategies, which could optimize its benefits and minimize any side effects.

What evidence suggests that MRT-6160 could be effective?

Research has shown that MRT-6160 yields promising results in early lab studies for various immune-related conditions. It works by breaking down a protein called VAV1, which affects immune cell function. This breakdown appears to lower the activity of T and B cells, which are involved in inflammation. In lab tests on mice, MRT-6160 slowed disease progression, suggesting potential for managing similar conditions in humans. However, MRT-6160 has not yet been tested in humans, so its effectiveness for people remains unknown. Participants in this trial will receive either a Single Ascending Dose or a Multiple Ascending Dose of MRT-6160 or a matching placebo to evaluate its safety and effects in healthy subjects. ^{1 3 4 6 7}

Who Is on the Research Team?

CRO

Principal Investigator

Celerion

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06597799

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

2. ir.monterosatx.com ir.monterosatx.com/news-releases/news-release-details/monte-rosa-therapeutics-presents-preclinical-data-acr-0

Release Details MRT-6160 has shown promising activity in preclinical models of multiple immune-mediated conditions. In a Phase 1, single ascending dose / ...

3. clinicaltrialsarena.com clinicaltrialsarena.com/news/mixed-data-results-for-two-monte-rosa-molecular-glue-degraders/

Mixed data results for two Monte Rosa molecular glue ... MRT-6160 saw success in its safety and tolerability study while MRT-235 fell short in across a number of indications. Credit: Shutterstock / ...

4. acrabstracts.org acrabstracts.org/abstract/mrt-6160-a-vav1-directed-molecular-glue-degrader-attenuates-t-and-b-cell-effector-functions-and-inhibits-disease-progression-in-a-spontaneous-mrl-faslpr-mouse-model/

MRT-6160, a VAV1-Directed Molecular Glue Degrader ... Results: MRT-6160 degraded VAV1 in healthy and pSS patient PBMCs, concomitant with an attenuation of TCR stimulation-induced IL-2 and T cell-dependent-like BCR ...

5. withpower.com withpower.com/trial/phase-1-healthy-subjects-hs-7-2024-8aa8e

MRT-6160 for Healthy Subjects · Info for Participants 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 ...

6. ir.monterosatx.com ir.monterosatx.com/news-releases/news-release-details/monte-rosa-therapeutics-announces-first-participants-dosed-mrt

Monte Rosa Therapeutics Announces First Participants ... The Phase 1 study of MRT-6160 is designed to provide early insights into safety, pharmacokinetics, VAV1 protein degradation, and key downstream pharmacodynamic ...

7. firstwordpharma.com firstwordpharma.com/story/5943506

Monte Rosa unveils first look at Novartis-backed molecular ... The Phase I study involving 70 healthy subjects demonstrated that MRT-6160 achieved sustained, dose-dependent VAV1 degradation in peripheral ...