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A multi-center, open-label, Phase 1/2a study is designed to assess the safety and efficacy of TI-168 in up to eighteen congenital hemophilia A (HA) patients with refractory inhibitors

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Trial Profile

A multi-center, open-label, Phase 1/2a study is designed to assess the safety and efficacy of TI-168 in up to eighteen congenital hemophilia A (HA) patients with refractory inhibitors

Status: Planning
Phase of Trial: Phase I/II

Latest Information Update: 21 Aug 2023

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At a glance

  • Drugs TI 168 (Primary) ; Emicizumab
  • Indications Haemophilia A
  • Focus Adverse reactions; First in man
  • Sponsors Baudax Bio; TeraImmune

Most Recent Events

  • 16 Aug 2023 According to a TeraImmune media release, the company is in the process of speaking with prospective investigators and assessing the readiness of potential study site staff and logistics for support of the clinical trial. The Company intends to select study sites and file for IRB (Investigational Review Board) approval at those study institutions. The Company estimates that the trial would be ready to open one or more initial study sites and begin to enroll patients in approximately Q1 of 2024.
  • 13 Oct 2022 New trial record
  • 11 Oct 2022 According to a TeraImmune media release, the U.S. Food and Drug Administration (FDA) has granted Investigational New Drug (IND) clearance to commence the Phase 1/2a clinical trial to evaluate, TI-168, in congenital Hemophilia A (HA) patients with refractory inhibitors.

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