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A Phase 1, Four-Part Study to Assess the Safety, Tolerability, Pharmacokinetics, and Gluten Degradation Activity of PvP001, PvP002, and PvP003 in Healthy Adult Volunteers and to Assess the Safety, Tolerability, and Pharmacokinetics of PvP001 and PvP002 in Adults With Celiac Disease

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Trial Profile

A Phase 1, Four-Part Study to Assess the Safety, Tolerability, Pharmacokinetics, and Gluten Degradation Activity of PvP001, PvP002, and PvP003 in Healthy Adult Volunteers and to Assess the Safety, Tolerability, and Pharmacokinetics of PvP001 and PvP002 in Adults With Celiac Disease

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 05 Apr 2023

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At a glance

  • Drugs Zamaglutenase (Primary)
  • Indications Coeliac disease
  • Focus Adverse reactions; Proof of concept; Therapeutic Use
  • Sponsors PvP Biologics; Takeda Oncology
  • Most Recent Events

    • 16 Mar 2021 Results published in the Gastroenterology
    • 04 Jan 2021 Planned End Date changed from 30 Jan 2021 to 28 Feb 2021.
    • 04 Jan 2021 Planned primary completion date changed from 20 Dec 2020 to 31 Jan 2021.
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