Subcutaneous Pharmacokinetics Study
Information source: Bristol-Myers Squibb
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Transplantation
Intervention: belatacept (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Bristol-Myers Squibb Official(s) and/or principal investigator(s): Bristol-Myers Squibb, Study Director, Affiliation: Bristol-Myers Squibb
Summary
Pharmacokinetics, Bioavailability, Safety and Immunogenicity of Single Doses of Belatacept
Administered Subcutaneously to Healthy Subjects
Clinical Details
Official title: Pharmacokinetics, Safety and Immunogenicity of Single Doses of Belatacept Administered Subcutaneously to Healthy Subjects
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care
Primary outcome: Pharmacokinetics
Secondary outcome: Safety will be based on review of AEs, vital signs, PEs, clinical lab tests, and injection site reactions. Immunogenicity will be measured based on antibody titers to belatacept
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Men and women ages 18 to 65 years old
- Subjects must weigh less than or equal to 100 kg
Exclusion Criteria:
- Inability to tolerate injections or IV infusions
- autoimmune disorders
- TB
- herpes
- HCV
- HBV
- HIV
- bacterial or viral infection
- history of cancer
Locations and Contacts
Ppd Development, Austin, Texas 78744, United States
Additional Information
BMS Clinical Trials Disclosure For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
Starting date: December 2007
Last updated: October 10, 2008
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