HealthyPhase 1NCT00619372
Oral OKT3 in Combination With Beta-D-Glucosylceramide
A Phase 1 study testing OKT3, OKT3, GC and GC in people with Healthy, run by Hadassah Medical Organization at 2 sites in 2 countries.
Trial 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] . Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- OKT3, OKT3, GC and GC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jan 2008to Jun 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects who have completed the informed consent process culminating with written informed consent by the subject.
- Men and women > 18 years of age.
Who cannot join
- 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.
Show all 21Show fewer
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Center for Neurologic Diseases, Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Administration of Anti-CD3 (OKT3) in Combination With Beta-D-Glucosylceramide
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] .
Read the 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
- Being tested
- OKT3, OKT3, GC, GC
- Keywords
- OKT3, beta-glucosylceramide, oral tolerance, anti-CD3, Safety assessment and healthy volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OKT3Drug
Also called OKT3, Monoclonal anti CD3.
0.2 mg OKT3, PO (in the mouth) on day 1 through 5.
OKT3, GCDrug
Also called OKT3, antiCD3, GC, glucosylceramide, beta glucosylceramide
0.2 mg OKT3 and 7.5 mg GC, PO (in the mouth) on day 1 through 5
OKT3Drug
Also called OKT3, antiCD3
1 mg OKT3, PO (in the mouth) on day 1 through 5
OKT3, GCDrug
Also called OKT3, antiCD3, GC, glucosylceramide, beta glucosylceramide
1 mg OKT3 and 7.5 mg GC, PO (in the mouth) on day 1 through 5
OKT3Drug
Also called OKT3, anti-CD3, GC, glucosylceramide, beta-glucosylceramide
5 mg OKT3, PO (in the mouth) on day 1 through 5
GCDrug
Also called GC, glucosylceramide, beta glucosylceramide
7.5 mg GC, PO (in the mouth) on day 1 through 5
| Study group | Role | What they receive |
|---|---|---|
| B | Experimental | Low dose OKT3 with GC Receives: Drug: OKT3, GC |
| C | Experimental | Mid dose OKT3 Receives: Drug: OKT3 |
| D | Experimental | Mid OKT3 dose with GC Receives: Drug: OKT3, GC |
| E | Experimental | High dose OKT3 Receives: Drug: OKT3 |
| F | Experimental | GC only Receives: Drug: GC |
| A | Experimental | Low dose OKT3 Receives: Drug: OKT3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: January-April
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2008 (estimated)
- Study startJan 2008
- Primary completionApr 2008
- Study completionJun 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Investigators
- Ehud Zigmond, M.D., Principal investigator, Hadassah University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00619372
- Sponsor's protocol ID
- YI002-HMO-CTIL
- Other IDs
- Protocol No. 01-300
- Status last verified
- Jan 2008
- First submitted
- 10 Feb 2008
- Last updated
- 4 Feb 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Administration of Anti-CD3 (OKT3) in Combination With Beta-D-Glucosylceramide
- ClinicalTrials.gov ID
- NCT00619372
- Acronym / sponsor ID
- YI002-HMO-CTIL
- Conditions
- Healthy
- Keywords
- OKT3, beta-glucosylceramide, oral tolerance, anti-CD3, Safety assessment and healthy volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Apr 2008 (actual)
- Study completion
- Jun 2008 (estimated)
- First posted
- 21 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| B | Experimental | Drug: OKT3, GCLow dose OKT3 with GC |
| C | Experimental | Drug: OKT3Mid dose OKT3 |
| D | Experimental | Drug: OKT3, GCMid OKT3 dose with GC |
| E | Experimental | Drug: OKT3High dose OKT3 |
| F | Experimental | Drug: GCGC only |
| A | Experimental | Drug: OKT3Low dose OKT3 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Subjects who have completed the informed consent process culminating with written informed consent by the subject.
- Men and women > 18 years of age.
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OKT3Also: OKT3, Monoclonal anti CD3.0.2 mg OKT3, PO (in the mouth) on day 1 through 5. | Drug | A |
| OKT3, GCAlso: OKT3, antiCD3, GC, glucosylceramide, beta glucosylceramide0.2 mg OKT3 and 7.5 mg GC, PO (in the mouth) on day 1 through 5 | Drug | B |
| OKT3Also: OKT3, antiCD31 mg OKT3, PO (in the mouth) on day 1 through 5 | Drug | C |
| OKT3, GCAlso: OKT3, antiCD3, GC, glucosylceramide, beta glucosylceramide1 mg OKT3 and 7.5 mg GC, PO (in the mouth) on day 1 through 5 | Drug | D |
| OKT3Also: OKT3, anti-CD3, GC, glucosylceramide, beta-glucosylceramide5 mg OKT3, PO (in the mouth) on day 1 through 5 | Drug | E |
| GCAlso: GC, glucosylceramide, beta glucosylceramide7.5 mg GC, PO (in the mouth) on day 1 through 5 | Drug | F |
Primary outcome
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
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ehud Zigmond, M.D. principal investigator
Hadassah University Hospital
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing OKT3, OKT3, GC and GC in people with Healthy, run by Hadassah Medical Organization at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2009.