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NCT00569803 Clinical Trial

Subcutaneous Pharmacokinetics Study

Transplantation Clinical Trial

Official title:
Pharmacokinetics, Safety and Immunogenicity of Single Doses of Belatacept Administered Subcutaneously to Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00569803
Other study ID # IM103-046
Secondary ID
Status Completed
Phase Phase 1
First received November 30, 2007
Last updated October 10, 2008
Start date December 2007
Est. completion date August 2008

Study information
Verified date September 2008
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

Pharmacokinetics, Bioavailability, Safety and Immunogenicity of Single Doses of Belatacept Administered Subcutaneously to Healthy Subjects

Recruitment information / eligibility
Status Completed
Enrollment 47
Est. completion date August 2008
Est. primary completion date August 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

Intervention

Drug:
• belatacept
single dose, 116 days

Locations
Country Name City State
United States Ppd Development Austin Texas

Sponsors (1)
Lead Sponsor Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pharmacokinetics will be taken over 56 days No
Secondary 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 taken over 116 days Yes
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