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A Phase 1, Randomized, Placebo-Controlled, Single Ascending Dose First-in-Human Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of VIS649 Administered Intravenously in Healthy Subjects

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Trial Profile

A Phase 1, Randomized, Placebo-Controlled, Single Ascending Dose First-in-Human Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of VIS649 Administered Intravenously in Healthy Subjects

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 10 Feb 2023

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At a glance

  • Drugs Sibeprenlimab (Primary)
  • Indications IgA nephropathy
  • Focus Adverse reactions; First in man
  • Sponsors Visterra
  • Most Recent Events

    • 11 Oct 2019 Status changed from recruiting to completed.
    • 12 Mar 2019 According to a Visterra media release, a fifth cohort was finalized after the study had started. Cohort 5 enrolled 15 adults randomized in a 2:1 ratio to receive VIS649 6.0 mg/kg or placebo on day 1, followed by a tetanus and diphtheria toxoid vaccine (TENIVAC, Sanofi Pasteur Limited) on day 28 (during the anticipated APRIL neutralization window) to evaluate the effect of APRIL suppression by VIS649 on recipients ability to generate a response to routine vaccine boost.
    • 23 Oct 2018 Status changed from planning to recruiting.
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