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
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

Additional relevant MeSH terms:
Abatacept
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 17, 2014