Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00258778
Status:
COMPLETED
Last Update Posted:
2006-12-05
First Post:
2005-11-23
Brief Title:
Phase I Single Dose-Escalation Safety Study of Human Glucocerebrosidase prGCD
Sponsor:
Protalix
Organization:
Protalix
Study Overview
Official Title:
A Phase I Non-Randomized Open Label Single Dose-Escalation Safety Study of Recombinant Human Glucocerebrosidase prGCD in Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2006-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Gaucher disease the most prevalent lysosomal storage disorder is caused by mutations in the human glucocerebrosidase gene GCDleading to reduced activity of the lysosomal enzyme glucocerebrosidase and thereby to the accumulation of substrate glucocerebroside GlcCerin the cells of the monocyte-macrophage system
This is the first trial to utilize a recombinant active form of lysosomal enzyme glucocerebrosidase human prGCDwhich is expressed and purified in a bioreactor system from transformed carrot plant root cell line
This is the first trial to utilize a recombinant active form of lysosomal enzyme glucocerebrosidase human prGCDwhich is expressed and purified in a bioreactor system from transformed carrot plant root cell line
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None