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A Phase 1 Randomized,Double-Blind and Parallel Controlled Single-dose Clinical Trial of Pharmacokinetics, Safety, Tolerability and Immunogenicity of HLX03 Compared With Humira From China Source in Chinese Healthy Male Subjects

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Trial Profile

A Phase 1 Randomized,Double-Blind and Parallel Controlled Single-dose Clinical Trial of Pharmacokinetics, Safety, Tolerability and Immunogenicity of HLX03 Compared With Humira From China Source in Chinese Healthy Male Subjects

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 05 Nov 2020

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At a glance

  • Drugs Adalimumab (Primary)
  • Indications Plaque psoriasis
  • Focus Pharmacokinetics
  • Sponsors Shanghai Henlius Biotech

    • Most Recent Events

    • 15 Jun 2019 Results assessing Pharmacokinetic equivalence and safety similarities between HLX03 and China sourced-adalimumab presented at the 20th Annual Congress of the European League Against Rheumatism.
    • 29 Nov 2018 Status changed from active, no longer recruiting to completed, according to the Shanghai Henlius Biotech media release.
    • 29 Nov 2018 According to a Shanghai Henlius Biotech media release, the company has completed data analysis of this trial.

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