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An Open Label, Single-dose, Dose-increasing Study to Assess the Safety, Tolerability, PK and Preliminary PD of PEGylated Recombinant Candida Urate Oxidase (SSS11) for Injection in Chinese Healthy Adult Volunteers

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Trial Profile

An Open Label, Single-dose, Dose-increasing Study to Assess the Safety, Tolerability, PK and Preliminary PD of PEGylated Recombinant Candida Urate Oxidase (SSS11) for Injection in Chinese Healthy Adult Volunteers

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 05 Jul 2023

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At a glance

  • Drugs Pegadricase (Primary)
  • Indications Gout; Tumour lysis syndrome
  • Focus Adverse reactions; Pharmacokinetics
  • Sponsors Shenyang Sunshine Pharmaceutical

    • Most Recent Events

    • 02 Jul 2021 Planned number of patients changed from 36 to 33.
    • 02 Jul 2021 Planned End Date changed from 30 Sep 2020 to 30 Dec 2022.
    • 02 Jul 2021 Planned primary completion date changed from 30 Jun 2020 to 30 Oct 2022.

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