A double blind, randomized, placebo-controlled, two-part, single ascending dose study to evaluate the pharmacokinetics, pharmacodynamics and immunosuppressive activity of Lulizumab Pegol in healthy volunteers (SAD study)

Trial Profile

A double blind, randomized, placebo-controlled, two-part, single ascending dose study to evaluate the pharmacokinetics, pharmacodynamics and immunosuppressive activity of Lulizumab Pegol in healthy volunteers (SAD study)

Completed
Phase of Trial: Phase I

Latest Information Update: 12 Jul 2016

At a glance

  • Drugs Lulizumab pegol (Primary) ; Lulizumab pegol (Primary)
  • Indications Systemic lupus erythematosus
  • Focus Adverse reactions; First in man; Pharmacodynamics; Pharmacokinetics
  • Sponsors Bristol-Myers Squibb
  • Most Recent Events

    • 22 Apr 2016 New trial record
    • 12 Mar 2016 Population pharmacokinetic/pharmacodynamic analysis (n=156) presented at the 117th Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics.
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