DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017