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Subcutaneous Pharmacokinetics Study

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00569803
First received: November 30, 2007
Last updated: October 10, 2008
Last verified: September 2008
  Purpose

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


Condition Intervention Phase
Transplantation
Drug: belatacept
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Official Title: Pharmacokinetics, Safety and Immunogenicity of Single Doses of Belatacept Administered Subcutaneously to Healthy Subjects

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Pharmacokinetics [ Time Frame: will be taken over 56 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Time Frame: taken over 116 days ] [ Designated as safety issue: Yes ]

Enrollment: 47
Study Start Date: December 2007
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A

SC Injection

Belatacept - 50 mg

Placebo - 0 mg

Drug: belatacept
single dose, 116 days
Active Comparator: B

SC Injection

Belatacept - 100 mg

Placebo - 0 mg

Drug: belatacept
single dose, 116 days
Active Comparator: C

SC Injection

Belatacept - 125 mg

Placebo - 0 mg

Drug: belatacept
single dose, 116 days
Active Comparator: D

SC Injection

Belatacept - 150 mg

Placebo - 0 mg

Drug: belatacept
single dose, 116 days
Active Comparator: E

SC Injection

Belatacept - 200 mg

Placebo - 0 mg

Drug: belatacept
single dose, 116 days
Active Comparator: F

SC Injection

Belatacept - 250 mg

Placebo - 0 mg

Drug: belatacept
single dose, 116 days
Active Comparator: G

IV Infusion

125 mg

Drug: belatacept
single dose, 116 days

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00569803

Locations
United States, Texas
Ppd Development
Austin, Texas, United States, 78744
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00569803     History of Changes
Other Study ID Numbers: IM103-046
Study First Received: November 30, 2007
Last Updated: October 10, 2008
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on November 27, 2014