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Oral OKT3 in Combination With Beta-D-Glucosylceramide

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00619372
Recruitment Status : Unknown
Verified January 2008 by Hadassah Medical Organization.
Recruitment status was:  Active, not recruiting
First Posted : February 21, 2008
Last Update Posted : February 4, 2009
Sponsor:
Information provided by:
Hadassah Medical Organization

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] .

Condition or disease Intervention/treatment Phase
Healthy Drug: OKT3 Drug: OKT3, GC Drug: GC Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Administration of Anti-CD3 (OKT3) in Combination With Beta-D-Glucosylceramide
Study Start Date : January 2008
Actual Primary Completion Date : April 2008
Estimated Study Completion Date : June 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: B
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
Other Names:
  • OKT3, antiCD3
  • GC, glucosylceramide, beta glucosylceramide

Experimental: C
Mid dose OKT3
Drug: OKT3
1 mg OKT3, PO (in the mouth) on day 1 through 5
Other Name: OKT3, antiCD3

Experimental: D
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
Other Names:
  • OKT3, antiCD3
  • GC, glucosylceramide, beta glucosylceramide

Experimental: E
High dose OKT3
Drug: OKT3
5 mg OKT3, PO (in the mouth) on day 1 through 5
Other Names:
  • OKT3, anti-CD3
  • GC, glucosylceramide, beta-glucosylceramide

Experimental: F
GC only
Drug: GC
7.5 mg GC, PO (in the mouth) on day 1 through 5
Other Name: GC, glucosylceramide, beta glucosylceramide

Experimental: A
Low dose OKT3
Drug: OKT3
0.2 mg OKT3, PO (in the mouth) on day 1 through 5.
Other Name: OKT3, Monoclonal anti CD3.




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00619372


Locations
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United States, Massachusetts
Center for Neurologic Diseases, Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Israel
Hadassah University Hospital
Jerusalem, Israel, 91120
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
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Principal Investigator: Ehud Zigmond, M.D. Hadassah University Hospital

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Responsible Party: Ehud Zigmond, M.D., Hadassah University Hospital
ClinicalTrials.gov Identifier: NCT00619372    
Other Study ID Numbers: YI002-HMO-CTIL
Protocol No. 01-300
First Posted: February 21, 2008    Key Record Dates
Last Update Posted: February 4, 2009
Last Verified: January 2008
Keywords provided by Hadassah Medical Organization:
OKT3
beta-glucosylceramide
oral tolerance
anti-CD3
Safety assessment and healthy volunteers
Additional relevant MeSH terms:
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Muromonab-CD3
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents