- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00619372
Oral OKT3 in Combination With Beta-D-Glucosylceramide
Administration of Anti-CD3 (OKT3) in Combination With Beta-D-Glucosylceramide
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
-
Jerusalem, Israel, 91120
- Hadassah University Hospital
-
-
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02115
- Center for Neurologic Diseases, Brigham and Women's Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: B
Low dose OKT3 with GC
|
0.2 mg OKT3 and 7.5 mg GC, PO (in the mouth) on day 1 through 5
Other Names:
1 mg OKT3 and 7.5 mg GC, PO (in the mouth) on day 1 through 5
Other Names:
|
EXPERIMENTAL: C
Mid dose OKT3
|
0.2 mg OKT3, PO (in the mouth) on day 1 through 5.
Other Names:
1 mg OKT3, PO (in the mouth) on day 1 through 5
Other Names:
5 mg OKT3, PO (in the mouth) on day 1 through 5
Other Names:
|
EXPERIMENTAL: D
Mid OKT3 dose with GC
|
0.2 mg OKT3 and 7.5 mg GC, PO (in the mouth) on day 1 through 5
Other Names:
1 mg OKT3 and 7.5 mg GC, PO (in the mouth) on day 1 through 5
Other Names:
|
EXPERIMENTAL: E
High dose OKT3
|
0.2 mg OKT3, PO (in the mouth) on day 1 through 5.
Other Names:
1 mg OKT3, PO (in the mouth) on day 1 through 5
Other Names:
5 mg OKT3, PO (in the mouth) on day 1 through 5
Other Names:
|
EXPERIMENTAL: F
GC only
|
7.5 mg GC, PO (in the mouth) on day 1 through 5
Other Names:
|
EXPERIMENTAL: A
Low dose OKT3
|
0.2 mg OKT3, PO (in the mouth) on day 1 through 5.
Other Names:
1 mg OKT3, PO (in the mouth) on day 1 through 5
Other Names:
5 mg OKT3, PO (in the mouth) on day 1 through 5
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
January-April
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
January-April
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ehud Zigmond, M.D., Hadassah University Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- YI002-HMO-CTIL
- Protocol No. 01-300
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy
-
Prevent Age Resort "Pervaya Liniya"RecruitingHealthy Aging | Healthy Diet | Healthy LifestyleRussian Federation
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
Yale UniversityNot yet recruitingHealth-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For HealthHealthy Diet | Healthy Lifestyle | Healthy Nutrition | CholesterolUnited States
-
Hasselt UniversityRecruitingHealthy | Healthy AgingBelgium
-
Galera Therapeutics, Inc.Syneos HealthCompleted
-
Galera Therapeutics, Inc.Syneos HealthCompletedHealthy | Healthy VolunteersAustralia
-
University of PennsylvaniaActive, not recruitingHealthy | Healthy AgingUnited States
-
Chalmers University of TechnologyGöteborg UniversityCompletedHealthy | Nutrition, HealthySweden
-
University of ManitobaNot yet recruitingHealthy | Healthy Diet
Clinical Trials on OKT3, GC
-
New York State Psychiatric InstituteSuspended
-
Yuval Y NeriaNot yet recruitingPosttraumatic Stress Disorder
-
Tulane UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompletedGonorrhea | Chlamydia Trachomatis InfectionUnited States
-
Marmara UniversityNot yet recruitingMolar-Incisor Hypomineralization
-
Green Cross CorporationCompleted
-
University of Colorado, DenverWithdrawn
-
Thomas S. ScanlanWithdrawnAdrenomyeloneuropathy | X-Linked AdrenoleukodystrophyUnited States
-
Green Cross CorporationCompleted
-
Isabel Cristina Olegário da CostaUniversity of Guadalajara; University of Dublin, Trinity College; Academic Centre...UnknownMolar Incisor HypomineralizationMexico