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Clinical trial

Comparative Pharmacokinetic and Pharmacodynamic Study Between 2 Agalsidase Beta Formulations at a Single Dose of 1 mg/kg of Agalsidase (Biosidus) and Fabrazyme (Sanofi Genzyme) as Intravenous Infusion in Male Healthy Volunteers

NCT05343715 is registered in ClinicalTrials.gov with Bio Sidus SA as lead sponsor.

NCT NCT05343715
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Registry record

As filed in ClinicalTrials.gov.

Title
Comparative Pharmacokinetic and Pharmacodynamic Study Between 2 Agalsidase Beta Formulations at a Single Dose of 1 mg/kg of Agalsidase (Biosidus) and Fabrazyme (Sanofi Genzyme) as Intravenous Infusion in Male Healthy Volunteers
Lead sponsor
Bio Sidus SA
Phase
Phase 1
Overall status
Completed
Start date
October 23, 2021
Completion date
April 17, 2022
Enrollment
24 (actual)
Sites
1

Conditions

As the registry lists them; a condition with its own page is linked.

fabry disease