Clinical Trials Logo
  1. Home
  2. Transplantation
  3. NCT00569803
  4. Details
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
See also
  Status Clinical Trial Phase
Completed NCT00838357 - A Multi-centre, Open Label, Single-arm Study Intended to Further Investigate the Safety and Efficacy of Plerixafor as a Front-line Mobilisation Agent in Combination With G-CSF in Patients With Lymphoma or MM (Multiple Myeloma). Phase 3
Terminated NCT00778856 - Hand Transplantation for the Reconstruction of Below the Elbow Amputations N/A
Active, not recruiting NCT00166842 - Sirolimus Blood Concentrations on Conversion From Oral Solution to Tablets Phase 4
Recruiting NCT04257747 - Qualitative and Quantitative Evaluation of Vascular Flows of Radial, Ulnar and Interdigital Arterial Trees Under Normal and Pathological Conditions by 3 Tesla MRI N/A
Completed NCT02560909 - Adjuvanted Influenza Vaccine in Stem Cell Transplant Phase 4
Active, not recruiting NCT01687192 - Multicenter Trial Evaluating the Immunogenicity of HPV Vaccination in Girls on Immunosuppressive Therapy. Phase 2
Completed NCT00951977 - Live Kidney Donor Study - Cross-Sectional and Historical Cohort Study N/A
Completed NCT00384202 - A Conversion Study to Assess Safety and Efficacy of a MR4 Based Immunosuppressive Regimen in Stable Liver Recipients Phase 3
Completed NCT00384137 - A Conversion Study to Assess Safety and Efficacy of a MR4 Based Immunosuppressive Regimen in Stable Kidney Recipients Phase 3
Completed NCT00235664 - Prospective Study of Drug Resistant Pathogens Among Liver, Intestinal and Multivisceral Transplant Recipients N/A
Completed NCT03533049 - mHealth Family Self-Management N/A
Completed NCT02826213 - Comparison of Two Techniques of Renal Pre-transplant Infusion on the Evolution of Renal Function in the Recipient
Completed NCT00170170 - Risk Factors for Cytomegalovirus Disease in Solid Organ Transplantation N/A
Recruiting NCT06367244 - Transplant Wellness Program N/A
Recruiting NCT06166186 - Effect of Intraoperative Music on Inflammatory Response in Donor Hepatectomy N/A
Recruiting NCT00493194 - Fibrosis in Renal Allografts Phase 4
Completed NCT00297310 - Pre-transplant Assessment of Tacrolimus Blood Level Concentration, as a Predictor of Tacrolimus Dose Requirements After Kidney Transplantation Phase 4
Completed NCT01019811 - Innervated Sensory Cross-Finger Flap N/A
Completed NCT04376775 - Assessment of the Impact of COVID-19 on Transplant Patients and on Patients Awaiting Transplantation
Active, not recruiting NCT00166816 - The Pharmacokinetics of Sirolimus When Combined With Cyclosporine or Tacrolimus in Renal Transplant Patients Phase 4

External Links