NCT00619372

Oral OKT3 in Combination With Beta-D-Glucosylceramide

Administration of Anti-CD3 (OKT3) in Combination With Beta-D-Glucosylceramide

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Hadassah Medical Organization · Academic / Other
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	OKT3	0.2 mg OKT3, PO (in the mouth) on day 1 through 5.
DRUG	OKT3, GC	0.2 mg OKT3 and 7.5 mg GC, PO (in the mouth) on day 1 through 5
DRUG	OKT3	1 mg OKT3, PO (in the mouth) on day 1 through 5
DRUG	OKT3, GC	1 mg OKT3 and 7.5 mg GC, PO (in the mouth) on day 1 through 5
DRUG	OKT3	5 mg OKT3, PO (in the mouth) on day 1 through 5
DRUG	GC	7.5 mg GC, PO (in the mouth) on day 1 through 5

Timeline

• Start date: 2008-01-01
• Primary completion: 2008-04-01
• Completion: 2008-06-01
• First posted: 2008-02-21
• Last updated: 2009-02-04

Locations

2 sites across 2 countries: United States, Israel