Oral OKT3 in Combination With Beta-D-Glucosylceramide

NCT ID: NCT00619372

Last Updated: 2009-02-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2008-06-30

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.

Conditions

Healthy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

B

Low dose OKT3 with GC

Group Type: EXPERIMENTAL

OKT3, GC

Intervention Type: DRUG

0.2 mg OKT3 and 7.5 mg GC, PO (in the mouth) on day 1 through 5

C

Mid dose OKT3

Group Type: EXPERIMENTAL

OKT3

Intervention Type: DRUG

1 mg OKT3, PO (in the mouth) on day 1 through 5

D

Mid OKT3 dose with GC

Group Type: EXPERIMENTAL

OKT3, GC

Intervention Type: DRUG

1 mg OKT3 and 7.5 mg GC, PO (in the mouth) on day 1 through 5

E

High dose OKT3

Group Type: EXPERIMENTAL

OKT3

Intervention Type: DRUG

5 mg OKT3, PO (in the mouth) on day 1 through 5

F

GC only

Group Type: EXPERIMENTAL

GC

Intervention Type: DRUG

7.5 mg GC, PO (in the mouth) on day 1 through 5

A

Low dose OKT3

Group Type: EXPERIMENTAL

OKT3

Intervention Type: DRUG

0.2 mg OKT3, PO (in the mouth) on day 1 through 5.

Interventions

OKT3

0.2 mg OKT3, PO (in the mouth) on day 1 through 5.

Intervention Type: DRUG

OKT3, GC

0.2 mg OKT3 and 7.5 mg GC, PO (in the mouth) on day 1 through 5

Intervention Type: DRUG

OKT3

1 mg OKT3, PO (in the mouth) on day 1 through 5

Intervention Type: DRUG

OKT3, GC

1 mg OKT3 and 7.5 mg GC, PO (in the mouth) on day 1 through 5

Intervention Type: DRUG

OKT3

5 mg OKT3, PO (in the mouth) on day 1 through 5

Intervention Type: DRUG

GC

7.5 mg GC, PO (in the mouth) on day 1 through 5

Intervention Type: DRUG

Other Intervention Names

OKT3, Monoclonal anti CD3.; OKT3, antiCD3; GC, glucosylceramide, beta glucosylceramide; OKT3, antiCD3; OKT3, antiCD3; GC, glucosylceramide, beta glucosylceramide; OKT3, anti-CD3; GC, glucosylceramide, beta-glucosylceramide; GC, glucosylceramide, beta glucosylceramide

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Hadassah Medical Organization

OTHER

Sponsor Role: lead

Responsible Party

Hadassah University Hospital

Principal Investigators

Ehud Zigmond, M.D.

Role: PRINCIPAL_INVESTIGATOR

Hadassah University Hospital

Locations

Center for Neurologic Diseases, Brigham and Women's Hospital

Boston, Massachusetts, United States

Hadassah University Hospital

Jerusalem, , Israel

Countries

United States; Israel

Other Identifiers

Protocol No. 01-300

Identifier Type: -

Identifier Source: secondary_id

YI002-HMO-CTIL

Identifier Type: -

Identifier Source: org_study_id