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Phase 1, First-in-Human, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose, Multiple Ascending Dose, and Food-Effect Study to Assess Safety, Tolerability, PK and PD of MRT-6160 in Healthy Subjects

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Trial Profile

Phase 1, First-in-Human, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose, Multiple Ascending Dose, and Food-Effect Study to Assess Safety, Tolerability, PK and PD of MRT-6160 in Healthy Subjects

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 12 Mar 2025

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At a glance

  • Drugs MRT 6160 (Primary)
  • Indications Autoimmune disorders
  • Focus Adverse reactions; First in man
  • Sponsors Monte Rosa Therapeutics

    • Most Recent Events

    • 11 Mar 2025 According to a Monte Rosa Therapeutics media release, company announced that management will present a pipeline update including clinical results from its Phase 1 SAD/MAD study of the VAV1-directed MGD MRT-6160 and its Phase 1/2 study of MRT-2359 in MYC-driven solid tumors in a conference call and webcast are planned for Thursday, March 20, 2025, at 8:00 a.m. ET.
    • 19 Aug 2024 Status changed from planning to recruiting, according to a Monte Rosa Therapeutics media release.
    • 19 Aug 2024 According to a Monte Rosa Therapeutics media release, the first participants have been dosed in a Phase 1, single ascending dose / multiple ascending dose (SAD/MAD), healthy volunteer study evaluating MRT-6160, a VAV1-directed MGD being developed for systemic and neurological autoimmune diseases. The Company expects to obtain initial data including biomarker data to demonstrate pharmacodynamic effects from the Phase 1 study in Q1 2025.

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