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Phase 1 first-in-human, randomized, double-blind, placebo-controlled, dose-ranging, single ascending dose (SAD) and multiple ascending dose (MAD) study of IW-601 in healthy volunteers.

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Trial Profile

Phase 1 first-in-human, randomized, double-blind, placebo-controlled, dose-ranging, single ascending dose (SAD) and multiple ascending dose (MAD) study of IW-601 in healthy volunteers.

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 27 Jun 2025

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At a glance

  • Drugs IW 601 (Primary)
  • Indications Inflammation; Inflammatory bowel diseases; Multiple sclerosis; Non-alcoholic steatohepatitis; Uveitis
  • Focus Adverse reactions; First in man
  • Acronyms POINTGUARD

Most Recent Events

  • 11 Jun 2025 According to an ImmuneWalk Therapeutics media release, this study continues to enroll subjects for the multiple ascending dose part and data from these cohorts is expected later in 2025. The SAD portion of the study met all of its primary and secondary endpoints.
  • 11 Jun 2025 According to an ImmuneWalk Therapeutics media release, the company presented positive topline data from the single ascending dose (SAD) portion of this trial in an oral presentation at EULAR 2025 conference in Barcelona.
  • 11 Jun 2025 According to an ImmuneWalk Therapeutics media release, primary endpoint (Safety and tolerability at all doses) has been met.

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