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Safety, Tolerability and Pharmacokinetics of Single Rising Intravenous Dose and Single Subcutaneous Dose of BI 655130 in Healthy Japanese Male Volunteers (Double-blind, Randomised, Placebo-controlled Design).

Trial Profile

Safety, Tolerability and Pharmacokinetics of Single Rising Intravenous Dose and Single Subcutaneous Dose of BI 655130 in Healthy Japanese Male Volunteers (Double-blind, Randomised, Placebo-controlled Design).

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 13 Mar 2024

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At a glance

  • Drugs Spesolimab (Primary) ; Spesolimab (Primary)
  • Indications Palmoplantar pustulosis; Pustular psoriasis; Ulcerative colitis
  • 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
  • 09 Jan 2018 Status changed from active, no longer recruiting to completed.
  • 06 Nov 2017 Planned End Date changed from 16 Dec 2017 to 5 Jan 2018.

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