Status:
COMPLETED
Vaccination Study of Abatacept (BMS-188667) for Normal Healthy Volunteers
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
Study to assess the ability of healthy subjects to build anitbodies to tetanus and pneumococcal vaccines after receiving a single intravenous dose of Abatacept, a drug which is being developed for the...
Eligibility Criteria
Inclusion
- Healthy Subjects
- Body Weight between 60 and 100 kg.
- Males and Females must be using adequate contraceptive methods during study and for 10 weeks after dose of study mediciation.
Exclusion
- Females who are prgnant or breastfeeding
- History of autoimmune disorder, immunodeficiency, or infection within past 3 months.
- Active TB requiring treatment within the previous 3 years.
- Positive breast cancer screen, PPD test.
- Vaccination with tetanus or pneumococcal vaccine within 5 years.
- Vaccination with any live vaccine within 4 weeks.
- History of drug or alcohol abuse.
- Any significant allergy.
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2005
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00279734
Start Date
August 1 2004
End Date
January 1 2005
Last Update
April 13 2011
Active Locations (3)
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1
Qutintiles Phase I Services
Lenexa, Kansas, United States
2
Parexel International Corp
Baltimore, Maryland, United States
3
PPD Development
Austin, Texas, United States