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Compare IBI305 to Avastin on the Pharmacokinetics, Safety, Tolerance and Immunogenicity of a Single Dose In Healthy Male Subjects: a Randomized Double-blind Parallel Controlled Phase I Clinical Study

Trial Profile

Compare IBI305 to Avastin on the Pharmacokinetics, Safety, Tolerance and Immunogenicity of a Single Dose In Healthy Male Subjects: a Randomized Double-blind Parallel Controlled Phase I Clinical Study

Completed
Phase of Trial: Phase I

Latest Information Update: 28 Jan 2019

At a glance

  • Drugs Bevacizumab (Primary)
  • Indications Colorectal cancer; Non-small cell lung cancer
  • Focus Pharmacokinetics; Registrational
  • Sponsors Innovent Biologics
  • Most Recent Events

    • 28 Jan 2019 According to an Innovent Biologics media release, based on the data of CIBI305A301 and CIBI305A201 studies, the National Medical Products Administration (NMPA) has accepted its new drug application (NDA) for bevacizumab biosimilar product, IBI-305.
    • 12 Dec 2018 According to an Innovent Biologics media release, pre-defined primary endpoints have been met in this trial and another trial- CIBI305A301.
    • 14 Oct 2018 Status changed from recruiting to completed, according to an Innovent Biologics media release.
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