Vaccination Study of Abatacept (BMS-188667) for Normal Healthy Volunteers

• Status: Completed
• Trial end date: 2005-01-01
• Target enrollment: 0
• Participant gender: All

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 treatment of Rheumatoid Arthritis and which can affect the immune system.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Abatacept; Vaccines

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.