Trials / Completed
CompletedNCT00258778
Phase I Single Dose-Escalation Safety Study of Human Glucocerebrosidase (prGCD)
A Phase I, Non-Randomized, Open Label, Single Dose-Escalation Safety Study of Recombinant Human Glucocerebrosidase (prGCD) in Healthy Volunteers
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 6 (planned)
- Sponsor
- Protalix · Industry
- Sex
- All
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
Summary
Gaucher disease, the most prevalent lysosomal storage disorder, is caused by mutations in the human glucocerebrosidase gene (GCD)leading to reduced activity of the lysosomal enzyme glucocerebrosidase and thereby to the accumulation of substrate glucocerebroside (GlcCer)in the cells of the monocyte-macrophage system. This is the first trial to utilize a recombinant active form of lysosomal enzyme, glucocerebrosidase, (human prGCD)which is expressed and purified in a bioreactor system from transformed carrot plant root cell line.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Human Glucocerebrosidase (prGCD) |
Timeline
- Start date
- 2005-11-01
- Completion
- 2006-01-01
- First posted
- 2005-11-28
- Last updated
- 2006-12-05
Source: ClinicalTrials.gov record NCT00258778. Inclusion in this directory is not an endorsement.