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A Phase 1C, open-label, single ascending dose study to evaluate the safety, tolerability, and pharmacokinetics of DM199 administered IV with PVC bag in adult healthy participants and adults recently taking ACE inhibitors

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Trial Profile

A Phase 1C, open-label, single ascending dose study to evaluate the safety, tolerability, and pharmacokinetics of DM199 administered IV with PVC bag in adult healthy participants and adults recently taking ACE inhibitors

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 21 Aug 2023

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At a glance

  • Drugs Rinvecalinase alfa (Primary)
  • Indications Renal failure; Stroke; Type 2 diabetes mellitus
  • Focus Adverse reactions
  • Sponsors DiaMedica Therapeutics

Most Recent Events

  • 14 Aug 2023 According to DiaMedica Therapeutics media release, the company completed an additional cohort of hypertensive patients (Part B) being treated with angiotensin-converting enzyme inhibitors (ACEi). This Phase 1C study is now finished and the Company is completing final closing procedures.
  • 05 Jun 2023 Planned End Date changed from 30 Jun 2023 to 31 Jul 2023.
  • 15 May 2023 According to DiaMedica Therapeutics media release, the results from this study will be included as additional supporting data in the Company's clinical hold response package to the FDA.

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