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Safety, Tolerability, and Pharmacokinetics of Two Dose Strengths of a Single Subcutaneous Dose of BI 655130 and One Single Intravenous Dose of BI 655130 in Healthy Male and Female Subjects (Open-label, Parallel Group Design)

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Trial Profile

Safety, Tolerability, and Pharmacokinetics of Two Dose Strengths of a Single Subcutaneous Dose of BI 655130 and One Single Intravenous Dose of BI 655130 in Healthy Male and Female Subjects (Open-label, Parallel Group Design)

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 20 Mar 2024

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At a glance

  • Drugs Spesolimab (Primary) ; Spesolimab (Primary)
  • Indications Pustular psoriasis
  • Focus Pharmacokinetics
  • 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
    • 12 Jan 2018 Status changed from active, no longer recruiting to completed.
    • 09 Jan 2018 Planned End Date changed from 29 Dec 2017 to 10 Jan 2018.

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