NCT00619372

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 \[GC\] .

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Jan 2008

Typical duration for phase_1 healthy

Geographic Reach
2 countries

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 10, 2008

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 21, 2008

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

February 4, 2009

Status Verified

January 1, 2008

Enrollment Period

3 months

First QC Date

February 10, 2008

Last Update Submit

February 3, 2009

Conditions

Healthy

Keywords

OKT3beta-glucosylceramideoral toleranceanti-CD3Safety assessment and healthy volunteers

Outcome Measures

Primary Outcomes (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.

    January-April

Secondary Outcomes (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.

    January-April

Study Arms (6)

B

EXPERIMENTAL

Low dose OKT3 with GC

Drug: OKT3, GC

C

EXPERIMENTAL

Mid dose OKT3

Drug: OKT3

D

EXPERIMENTAL

Mid OKT3 dose with GC

Drug: OKT3, GC

E

EXPERIMENTAL

High dose OKT3

Drug: OKT3

F

EXPERIMENTAL

GC only

Drug: GC

A

EXPERIMENTAL

Low dose OKT3

Drug: OKT3

Interventions

OKT3DRUG

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

Also known as: OKT3, Monoclonal anti CD3.
A
OKT3, GCDRUG

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

Also known as: OKT3, antiCD3, GC, glucosylceramide, beta glucosylceramide
B
GCDRUG

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

Also known as: GC, glucosylceramide, beta glucosylceramide
F

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Center for Neurologic Diseases, Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Hadassah University Hospital

Jerusalem, 91120, Israel

Location

MeSH Terms

Interventions

Muromonab-CD3Glucosylceramides

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsImmunoglobulin GImmunoglobulin IsotypesSerum GlobulinsGlobulinsCerebrosidesCeramidesAmidesOrganic ChemicalsNeutral GlycosphingolipidsGlycosphingolipidsGlycolipidsGlycoconjugatesCarbohydratesLipidsSphingolipidsMembrane Lipids

Study Officials

  • Ehud Zigmond, M.D.

    Hadassah University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 10, 2008

First Posted

February 21, 2008

Study Start

January 1, 2008

Primary Completion

April 1, 2008

Study Completion

June 1, 2008

Last Updated

February 4, 2009

Record last verified: 2008-01

Locations

IL(1)US(1)