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A Phase I, Dose-Escalating Study to Evaluate the Safety and Pharmacokinetics of Single and Multiple Intrathecal Infusion of KP-100IT through SM-1500 in Subjects with Amyotrophic Lateral Sclerosis (ALS).

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Trial Profile

A Phase I, Dose-Escalating Study to Evaluate the Safety and Pharmacokinetics of Single and Multiple Intrathecal Infusion of KP-100IT through SM-1500 in Subjects with Amyotrophic Lateral Sclerosis (ALS).

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 14 Jan 2019

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At a glance

  • Drugs Oremepermin alfa (Primary)
  • Indications Amyotrophic lateral sclerosis
  • Focus Adverse reactions; First in man
  • Sponsors Kringle Pharma

    • Most Recent Events

    • 11 Dec 2018 Results published in the Journal of Clinical Pharmacology
    • 13 Jul 2015 Planned number of patients changed from 12 to 15 as per University Hospital Medical Information Network - Japan.
    • 11 Mar 2015 According to Kringle Pharm media release, status changed from active, no longer recruiting to completed.

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