A Phase I, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Intravenous and Subcutaneous rhuMAb Beta7 Administered in a Single-Dose, Dose-Escalation Stage Followed by a Multidose, Parallel-Treatment Stage in Patients With Ulcerative Colitis.

Trial Profile

A Phase I, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Intravenous and Subcutaneous rhuMAb Beta7 Administered in a Single-Dose, Dose-Escalation Stage Followed by a Multidose, Parallel-Treatment Stage in Patients With Ulcerative Colitis.

Completed
Phase of Trial: Phase I

Latest Information Update: 04 Sep 2016

At a glance

  • Drugs Etrolizumab (Primary) ; Etrolizumab (Primary)
  • Indications Ulcerative colitis
  • Focus Adverse reactions
  • Sponsors Genentech
  • Most Recent Events

    • 20 Jun 2012 Results published in Gut.
    • 12 Jun 2012 Status changed from active, no longer recruiting to completed.
    • 20 Mar 2012 Planned end date 1 Nov 2012 added as reported by ClinicalTrials.gov.
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