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] .
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.
- Subjects who have completed the informed consent process culminating with written
informed consent by the subject.
- Men and women > 18 years of age.
- Subjects who have undergone surgery within the last 3 months.
- Subjects who have had a prior colostomy, ileostomy, or colectomy with ileorectal
- 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
- 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