A Randomized, Double Blind, Placebo-controlled, Pharmacokinetics/Pharmacodynamics-guided, Phase I Study in Healthy Volunteers Given Escalating, Single Intravenous Doses of NI-0101 in the Absence and Then in the Presence of a Systemic Lipopolysaccharide Challenge.

Trial Profile

A Randomized, Double Blind, Placebo-controlled, Pharmacokinetics/Pharmacodynamics-guided, Phase I Study in Healthy Volunteers Given Escalating, Single Intravenous Doses of NI-0101 in the Absence and Then in the Presence of a Systemic Lipopolysaccharide Challenge.

Completed
Phase of Trial: Phase I

Latest Information Update: 05 Oct 2016

At a glance

  • Drugs NI 0101 (Primary)
  • Indications Inflammation
  • Focus Adverse reactions; First in man
  • Sponsors NovImmune SA
  • Most Recent Events

    • 05 Oct 2016 Safety, pharmacokinetic and pharmacodynamic results (n=73) published in the Clinical Pharmacology and Therapeutics.
    • 02 Nov 2015 Results will be presented at the 2015 Annual Meeting of the American College of Rheumatology (ACR), according to a Novimmune SA media release.
    • 05 Aug 2014 Status changed from recruiting to completed, according to a Novimmune media release.
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