PK/PD Study of 2 Agalsidase Formulations in Single Dose of 1 mg/kg Administered to Healthy Volunteers as IV Infusion

PHASE1CompletedINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

October 23, 2021

Primary Completion Date

March 6, 2022

Study Completion Date

April 17, 2022

Conditions
Fabry Disease
Interventions
BIOLOGICAL

Agalsidase beta from Biosidus 1 mg/kg

Patients received an infusion of 1 mg/kg of Agalsidase Beta from Biosidus. Final infusion dose is achieved with lyophilized drug at concentration 35 mg and 5 mg

BIOLOGICAL

Fabrazyme (agalsidase beta) 1 mg/kg

Patients received an infusion of 1 mg/kg of Fabrazyme. Final infusion dose is achieved with lyophilized drug at concentration 35 mg and 5 mg

Trial Locations (1)

1702

Sanatorio Nuestra Señora del Pilar, Ciudadela

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bio Sidus SA

INDUSTRY