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A Single-center, Randomized, Double-blind, Placebo-controlled Phase I Clinical Study to Evaluate the Tolerability, Safety, and PK Characteristics of SIM1910-09 After Single/Multiple Dosing in Healthy Chinese Volunteers

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Trial Profile

A Single-center, Randomized, Double-blind, Placebo-controlled Phase I Clinical Study to Evaluate the Tolerability, Safety, and PK Characteristics of SIM1910-09 After Single/Multiple Dosing in Healthy Chinese Volunteers

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 04 Dec 2023

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At a glance

  • Drugs AER-271 (Primary)
  • Indications Brain oedema
  • Focus Adverse reactions; First in man
  • Sponsors Simcere Pharmaceutical Group
  • Most Recent Events

    • 27 Nov 2023 Status changed from recruiting to completed.
    • 16 Dec 2021 New trial record
    • 09 Dec 2021 According to an Aeromics media release, in April 2021, the China National Medical Products Administration (NMPA) approved a clinical trial of SIM0307 for the indication of cerebral edema after acute severe ischemic stroke.
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