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Sponsored by: |
Protalix |
Information provided by: | Protalix |
ClinicalTrials.gov Identifier: | NCT00258778 |
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.
Condition | Intervention | Phase |
Gaucher Disease |
Drug: Human Glucocerebrosidase (prGCD) |
Phase I |
MedlinePlus related topics: | Gaucher's Disease |
ChemIDplus related topics: | Alglucerase Imiglucerase |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety Study |
Official Title: | A Phase I, Non-Randomized, Open Label, Single Dose-Escalation Safety Study of Recombinant Human Glucocerebrosidase (prGCD) in Healthy Volunteers |
Estimated Enrollment: | 6 |
Study Start Date: | November 2005 |
Estimated Study Completion Date: | January 2006 |
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | P-01-2005 |
First Received: | November 23, 2005 |
Last Updated: | December 4, 2006 |
ClinicalTrials.gov Identifier: | NCT00258778 |
Health Authority: | United States: Food and Drug Administration |
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