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A Phase 1/2 Open-label, Dose Escalation Study Followed by a Multi-center, Randomized, Double-blind, Dose Comparison Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics of CAN103 in Newly Treated Gaucher Disease

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Trial Profile

A Phase 1/2 Open-label, Dose Escalation Study Followed by a Multi-center, Randomized, Double-blind, Dose Comparison Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics of CAN103 in Newly Treated Gaucher Disease

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 23 May 2025

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At a glance

  • Drugs Glucocerebrosidase CANbridge (Primary)
  • Indications Gaucher's disease type I; Gaucher's disease type III
  • Focus First in man; Registrational; Therapeutic Use
  • Sponsors CANbridge Pharmaceuticals

Most Recent Events

  • 16 May 2025 According to Canbridge Pharmaceuticals media release, Contract Research, Development and Manufacturing Organization (CRDMO), congratulates its partner CANbridge Pharmaceuticals on the approval of its innovative velaglucerase-beta for injection (Gaurunning) by the China National Medical Products Administration (NMPA) for the treatment of adolescents aged 12 and above and adults with type I and type III Gaucher disease.
  • 13 Mar 2025 Primary endpoint(Mean percentage reduction from baseline in spleen volume at nine months for both the 60 U/kg dose and the lower 30 U/kg dose) has been met.
  • 13 Mar 2025 According to Canbridge Pharmaceuticals media release, company announced that the pivotal clinical trial of CAN103 achieved positive top-line data in August 2024.

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