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A Phase 1, First-in-human, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GIM-407 in Healthy Adult Participants

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Trial Profile

A Phase 1, First-in-human, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GIM-407 in Healthy Adult Participants

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 22 Jul 2025

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At a glance

  • Drugs GIM 407 (Primary)
  • Indications Autoimmune disorders
  • Focus Adverse reactions; First in man
  • Sponsors Georgiamune

Most Recent Events

  • 10 Jul 2025 Status changed from recruiting to completed.
  • 11 Mar 2025 Planned primary completion date changed from 1 Feb 2025 to 1 Mar 2025.
  • 10 Jan 2025 Planned number of patients changed from 64 to 80.

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