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A Single-Center, Phase I, Randomized, Double Blind, Placebo-Controlled, First-In-Human Trial to Assess the Safety, Tolerability, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of Subcutaneous Injected M6495 (Anti-ADAMTS-5 Nanobody) in Healthy Male Subjects

Trial Profile

A Single-Center, Phase I, Randomized, Double Blind, Placebo-Controlled, First-In-Human Trial to Assess the Safety, Tolerability, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of Subcutaneous Injected M6495 (Anti-ADAMTS-5 Nanobody) in Healthy Male Subjects

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 10 Dec 2018

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At a glance

  • Drugs M 6495 (Primary)
  • Indications Osteoarthritis
  • Focus Adverse reactions; First in man
  • Sponsors Merck KGaA
  • Most Recent Events

    • 07 Sep 2018 Status changed from active, no longer recruiting to completed.
    • 19 Jul 2018 Status changed from recruiting to active, no longer recruiting.
    • 12 Apr 2018 Planned number of patients changed from 45 to 54.
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