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A phase I, randomized, double-blind, placebo-controlled, ascending dose study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of IMVT-1402 following single and multiple doses in healthy participants and open-label cohorts in participants with autoimmune diseases

Trial Profile

A phase I, randomized, double-blind, placebo-controlled, ascending dose study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of IMVT-1402 following single and multiple doses in healthy participants and open-label cohorts in participants with autoimmune diseases

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 19 Nov 2024

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At a glance

  • Drugs IMVT-1402 (Primary) ; IMVT-1402 (Primary)
  • Indications Autoimmune disorders
  • Focus Adverse reactions; First in man
  • Sponsors Immunovant

Most Recent Events

  • 09 Sep 2024 According to an Immunovant media release, company announced alignment with the U.S. Food & Drug Administration (FDA) and Investigational New Drug Application (IND) clearance with initiation of a pivotal trial of IMVT-1402 in GD expected by December 31, 2024
  • 20 Mar 2024 Results of topline data published in OmniAB media release.
  • 11 Mar 2024 Protocol of study has been amended to include patients with autoimmune diseases and part 2 of study has been added which is open lable

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