NCT02995993

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

An Open-Label, Multi-Center Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Moss-aGal in Patients With Fabry Disease

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Greenovation Biotech GmbH · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Fabry Disease

Interventions

Type	Name	Description
DRUG	Moss-aGal (recombinant human alpha-galactosidase A produced in moss)	Single i.v. Infusion of 0.2 mg/kg moss-aGal over 60 minutes

Timeline

• Start date: 2016-11-01
• Primary completion: 2017-10-09
• Completion: 2017-10-09
• First posted: 2016-12-19
• Last updated: 2017-12-13

Locations

2 sites across 1 country: Germany