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Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Intravenous Doses of BI 655130 (Double-blind, Partially Randomised Within Dose Groups, Placebo-controlled Parallel Group Design) and One Single Intravenous Dose of BI 655130 (Single-blind, Partially Randomised, Placebo-controlled) in Healthy Male Subjects

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Trial Profile

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Intravenous Doses of BI 655130 (Double-blind, Partially Randomised Within Dose Groups, Placebo-controlled Parallel Group Design) and One Single Intravenous Dose of BI 655130 (Single-blind, Partially Randomised, Placebo-controlled) in Healthy Male Subjects

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 20 Mar 2024

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At a glance

  • Drugs Spesolimab (Primary)
  • Indications Unspecified
  • Focus Adverse reactions
  • Sponsors Boehringer Ingelheim

    • Most Recent Events

    • 01 Dec 2022 Results from Phase I Clinical Studies ( NCT02525679, NCT02852824, NCT03100903, NCT03123094, NCT03617835 ) assessing pharmacokinetics of spesolimab and evaluate changes with respect to dose, frequency of dosing, formulation and injection site. Immunogenicity, safety and tolerability published in the Clinical Pharmacokinetics
    • 22 Aug 2017 Status changed from active, no longer recruiting to completed.
    • 18 Apr 2017 Status changed from recruiting to active, no longer recruiting.

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