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A Phase I/II, first-in-human, single and multiple ascending dose study to investigate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of HMB-001 in participants With Glanzmann thrombasthenia

Trial Profile

A Phase I/II, first-in-human, single and multiple ascending dose study to investigate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of HMB-001 in participants With Glanzmann thrombasthenia

Status: Active, no longer recruiting
Phase of Trial: Phase I/II

Latest Information Update: 17 Mar 2026

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At a glance

  • Drugs Sutacimig (Primary)
  • Indications Thrombasthenia
  • Focus Adverse reactions; First in man; Therapeutic Use
  • Sponsors Hemab

Most Recent Events

  • 05 Mar 2026 According to a Hemab media release, based positive results from the completed Phase 2 multiple ascending dose portion the U.S. FDA has granted Breakthrough Therapy Designation (BTD) for sutacimig for the prevention of bleeding episodes in patients with Glanzmann thrombasthenia (GT).
  • 08 Dec 2025 According to a Hemab media release, data from this study was presented in an oral session at the 67th American Society of Hematology (ASH) Annual Meeting in Orlando
  • 08 Dec 2025 Results presented in the Hemab Media Release.

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