2 results
Approved WMOCompleted
To obtain the safety and effectiveness data necessary to support a Premarket Approval (PMA) Application to the U.S. Food and Drug Administration (FDA)
Approved WMOCompleted
The primary objectives of this study are: * To characterize the effects of 150 mg and 450 mg of AT1001 administered 2 hours before administration of agalsidase on the safety and plasma pharmacokinetics of agalsidase in subjects with Fabry Disease*…