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Agalsidase beta biosimilar vs Fabrazyme in healthy volunteers
NCT05343715Phase 1Completed
- Sponsor
- Biosidus
- Start
- Oct 2021
- Primary completion
- Mar 2022
- Modality
- Replacement Enzymes
- Countries
- 1
01
Overview
Phase 1, randomised, open-label trial of agalsidase beta in Fabry disease (FD) (2 arms), sponsored by Biosidus. Primary endpoints: Maximum Serum Concentration of Agalsidase Beta at 12 hours, Area Under the Curve of Serum Concentration Between Times 0 and 12 Hours and 2 more. Started Oct 2021; status: completed.
02
Drugs
agalsidase beta
03
Conditions
Fabry disease (FD)
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