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A Phase 1, First-in-Human, 2-Part, Multicenter Dose Escalation and Repeat Dose Study of the Safety, Tolerability and Pharmacokinetics of TIMP-GLIA in Subjects With Celiac Disease

Trial Profile

A Phase 1, First-in-Human, 2-Part, Multicenter Dose Escalation and Repeat Dose Study of the Safety, Tolerability and Pharmacokinetics of TIMP-GLIA in Subjects With Celiac Disease

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 24 Mar 2021

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At a glance

  • Drugs TAK 101 (Primary)
  • Indications Coeliac disease
  • Focus Adverse reactions; First in man; Pharmacodynamics; Pharmacokinetics
  • Sponsors Takeda
  • Most Recent Events

    • 12 Mar 2021 Results of phase 1 and phase 2a studies assessing safety, tolerability, pharmacokinetics, and efficacy of TAK-101 from the induction of gliadin specific T-cell tolerance in patients with biopsy confirmed CeD, published in the Gastroenterology.
    • 18 Jun 2019 Status changed from active, no longer recruiting to completed.
    • 29 Jan 2019 Planned End Date changed from 1 Mar 2019 to 29 May 2019.
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