Overview

Pharmacokinetics, Pharmacodynamics, and Safety of Moss-aGalactosidase A in Patients With Fabry Disease

Status:
Completed
Trial end date:
2017-10-09
Target enrollment:
Participant gender:
Summary
Six patients with Fabry disease will be recruited. Patients will receive a single dose of 0.2 mg/kg recombinant human alpha-galactosidase A produced in moss (moss-aGal) as intravenous infusion. Patients will be hospitalized during the infusion and for at least 24 hours after the end of the infusion. Treatment will be administered sequentially: if a patient shows no safety concerns on the treatment day, treatment of the next patient will commence on the following day.
Phase:
Phase 1
Details
Lead Sponsor:
Greenovation Biotech GmbH
Collaborator:
FGK Clinical Research GmbH