Status:
UNKNOWN
Oral OKT3 in Combination With Beta-D-Glucosylceramide
Lead Sponsor:
Hadassah Medical Organization
Conditions:
Healthy
Eligibility:
MALE
18-50 years
Phase:
PHASE1
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 immu...
Eligibility Criteria
Inclusion
- Subjects who have completed the informed consent process culminating with written informed consent by the subject.
- Men and women \> 18 years of age.
Exclusion
- Subjects who have undergone surgery within the last 3 months.
- Subjects who have had a prior colostomy, ileostomy, or colectomy with ileorectal anastamosis.
- Subjects presenting with, or who have a history of, persistent intestinal obstruction, bowel perforation, uncontrolled bleeding or abdominal abscess or infection, toxic megacolon.
- Subjects with a clinically significant infectious, immune mediated or malignant disease
- Subjects who are receiving an elemental diet or parenteral nutrition.
- Subjects who have been treated with any time of immune modulatory drug including steroids or NSAID within the last 4 weeks.
- Subjects who have received either methotrexate or cyclosporine or anti TNF alpha (infliximab, Remicade), anti-integrin (namixilab) or who have participated in any other clinical trial within the last 3 months.
- Subjects with a history of coagulopathy.
- Women with childbearing potential unless surgically sterile or using adequate contraception (either IUD, oral or Depo -provera contraceptive, or barrier plus spermicide); pregnant or breastfeeding mothers.
- Subjects who will be unavailable for the duration of the trial, are likely to be non¬compliant with the protocol, or who are felt to be unsuitable by the investigator for any other reason.
- Subjects who are HIV positive
- Subjects who are HBsAg positive
- Subjects who are HCV positive
- Subjects with active CMV
- Subjects who demonstrate a positive PPD
- Subjects with anemia (Hb \<10.5 gm/dl)
- Subjects with thrombocytopenia (platelets \<100K/microliter)
- Subjects with lymphopenia (absolute lymphocyte count \<0.7)
- Subjects with IgG anti-cardiolipin antibody \>16 IU
- Prior exposure to OKT3
- Known sensitivity to any ingredients in the study drug
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2008
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00619372
Start Date
January 1 2008
End Date
June 1 2008
Last Update
February 4 2009
Active Locations (2)
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1
Center for Neurologic Diseases, Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
2
Hadassah University Hospital
Jerusalem, Israel, 91120