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A Randomized Double-blind Placebo-controlled Phase I Study on the Safety, Tolerability and Pharmacokinetics/-Dynamics of Escalating Single Intravenous Doses of ADRECIZUMAB (HAM8101) in Healthy Male Subjects During Experimental Endotoxemia

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Trial Profile

A Randomized Double-blind Placebo-controlled Phase I Study on the Safety, Tolerability and Pharmacokinetics/-Dynamics of Escalating Single Intravenous Doses of ADRECIZUMAB (HAM8101) in Healthy Male Subjects During Experimental Endotoxemia

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 09 Feb 2022

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At a glance

  • Drugs Enibarcimab (Primary)
  • Indications Septic shock
  • Focus Adverse reactions
  • Sponsors Adrenomed

    • Most Recent Events

    • 29 Jan 2021 Status changed from active, no longer recruiting to completed.
    • 19 Dec 2018 According to an Adrenomed media release, results of the two phase I trials (NCT02991508 and NCT03083171) were presented by Dr. Jens Zimmermann (Chief Medical Officer of Adrenomed AG) at the 2nd scientific symposium (Endothelial Dysfunction-Adrenomedullin as a diagnostic and therapeutic target) which was hosted by Adrenomed AG.
    • 01 Jun 2018 Results assessing safety, tolerability and PK/PD of Adrecizumab in two randomised studies ( NCT02991508 and NCT03083171) published in the British Journal of Clinical Pharmacology
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