Oral OKT3 in Combination With Beta-D-Glucosylceramide

Status unconfirmed · Phase 1

Conditions studied: Healthy

In brief

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 \[GC\] .

Key facts

Study ID

NCT00619372

Run by

Hadassah Medical Organization

People needed

20

Starts

2008-01-01

Expected to finish

2008-06-01

Last updated by the study team

2009-02-04

Who can join

Age: 18 and older, up to 50. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• Subjects who have completed the informed consent process culminating with written informed consent by the subject.
• Men and women > 18 years of age.

You may not qualify if…

• 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

Where it is running

• Center for Neurologic Diseases, Brigham and Women's Hospital — Boston, Massachusetts, United States
• Hadassah University Hospital — Jerusalem, Israel

Full record on ClinicalTrials.gov

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