Ignite Creation Date:
2024-05-05 @ 7:08 PM
Last Modification Date:
2024-10-26 @ 9:45 AM
Study NCT ID:
NCT00619372
Status:
UNKNOWN
Last Update Posted:
2009-02-04
First Post:
2008-02-10
Brief Title:
Oral OKT3 in Combination With Beta-D-Glucosylceramide
Sponsor:
Hadassah Medical Organization
Organization:
Hadassah Medical Organization
Study Overview
Official Title:
Administration of Anti-CD3 OKT3 in Combination With Beta-D-Glucosylceramide
Status:
UNKNOWN
Status Verified Date:
2008-01
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This clinical study is designed to evaluate the safety of oral administration of the study drug anti CD3 OKT3 in combination with β-D glucosylceramide GC
Detailed Description:
Anti CD3 OKT3 Is an approved drug for intravenous use in the treatment of solid organ transplantation Preliminary data suggest that the oral administration of OKT3 in low dosages can exert an immune modulatory effect via activation of regulatory T lymphocytes
β-D glucosylceramide GC Is approved for oral administration and is currently being tested in three clinical trials Recent data suggested that it can serve as an immunological adjuvant in various clinical settings and to augment the immune response via activation of regulatory T cells
This clinical trial has been designed to assess the safety of oral administration of OKT3 with and without co-administration of GC in healthy subjects The use of two potential activators of regulatory T cells may exert an additive effect augmenting the systemic immune modulatory effect
β-D glucosylceramide GC Is approved for oral administration and is currently being tested in three clinical trials Recent data suggested that it can serve as an immunological adjuvant in various clinical settings and to augment the immune response via activation of regulatory T cells
This clinical trial has been designed to assess the safety of oral administration of OKT3 with and without co-administration of GC in healthy subjects The use of two potential activators of regulatory T cells may exert an additive effect augmenting the systemic immune modulatory effect
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Protocol No 01-300 | None | None | None |