Oral OKT3 in Combination With Beta-D-Glucosylceramide - Full Text View

Sponsored by:	Hadassah Medical Organization
Information provided by:	Hadassah Medical Organization
ClinicalTrials.gov Identifier:	NCT00619372

Purpose

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] .

Condition	Intervention	Phase
Healthy	Drug: OKT3 Drug: OKT3, GC Drug: GC	Phase I

Drug Information available for: Visilizumab Muromonab CD3

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Official Title:	Administration of Anti-CD3 (OKT3) in Combination With Beta-D-Glucosylceramide

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:

Assessment of the safety of oral administration of OKT3 with and without GC in healthy volunteers by monitoring the subjects for adverse events and by interpreting the results of the various laboratory tests and the subjects' diaries. [ Time Frame: January-April ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To evaluate the safety of 5 consecutive doses of oral OKT3 with and with out GC and the dose escalation effect in healthy volunteers. [ Time Frame: January-April ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	20
Study Start Date:	January 2008
Estimated Study Completion Date:	June 2008
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
B: Experimental Low dose OKT3 with GC	Drug: OKT3, GC 0.2 mg OKT3 and 7.5 mg GC, PO (in the mouth) on day 1 through 5
C: Experimental Mid dose OKT3	Drug: OKT3 1 mg OKT3, PO (in the mouth) on day 1 through 5
D: Experimental Mid OKT3 dose with GC	Drug: OKT3, GC 1 mg OKT3 and 7.5 mg GC, PO (in the mouth) on day 1 through 5
E: Experimental High dose OKT3	Drug: OKT3 5 mg OKT3, PO (in the mouth) on day 1 through 5
F: Experimental GC only	Drug: GC 7.5 mg GC, PO (in the mouth) on day 1 through 5
A: Experimental Low dose OKT3	Drug: OKT3 0.2 mg OKT3, PO (in the mouth) on day 1 through 5.

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.

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00619372

Contacts

Contact: Yaron Ilan, M.D.	972-2-677-8231	ilan@hadassah.org.il
Contact: Deborah Mautner	972-50-8946943	deborah@hadassah.org.il

Locations

United States, Massachusetts
Center for Neurologic Diseases, Brigham and Women's Hospital	Active, not recruiting
Boston, Massachusetts, United States, 02115
Israel
Hadassah University Hospital	Recruiting
Jerusalem, Israel, 91120
Contact: Nilla Hemed, RN 972-2-677-7990
Contact: Deborah Mautner 972-50-894-6943 deborah@hadassah.org.il
Sub-Investigator: Gadi Lalazar, M.D.
Principal Investigator: Ehud Zigmond, M.D.
Sub-Investigator: Yaron Ilan, M.D.

Sponsors and Collaborators

Hadassah Medical Organization

Investigators

Principal Investigator:

Ehud Zigmond, M.D.

Hadassah University Hospital

More Information

Responsible Party:	Hadassah University Hospital ( Ehud Zigmond, M.D. )
Study ID Numbers:	YI002-HMO-CTIL, Protocol No. 01-300
Study First Received:	February 10, 2008
Last Updated:	February 20, 2008
ClinicalTrials.gov Identifier:	NCT00619372
Health Authority:	Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Hadassah Medical Organization:

OKT3
beta-glucosylceramide
oral tolerance
anti-CD3
Safety assessment and healthy volunteers

Study placed in the following topic categories:

Healthy
Muromonab-CD3

Additional relevant MeSH terms:

Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009