Pharmacokinetic Study to Compare the Blood Levels of Abatacept Manufactured at Lonza Biologics to the Blood Levels of Abatacept Manufactured at the Devens, Massachusetts (MA) Facility of Bristol-Myers Squibb

Bristol-Myers Squibb (BMS)

Status and phase

Completed

Phase 1

Conditions

Rheumatoid Arthritis

Treatments

Biological: Abatacept (BMS-188667)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01439204

IM101-292

Details and patient eligibility

About

The purpose of this study is to determine whether the blood levels of Abatacept (BMS-188667) drug product manufactured at Lonza Biologics and the Devens, MA facility of Bristol-Myers Squibb are comparable in healthy subjects

Full description

Primary Purpose of this study is to compare the pharmacokinetic (PK) of Abatacept (BMS-188667) manufactured at Lonza relative to Abatacept (BMS-188667) manufactured at Devens, MA facility following a single intravenous infusion of 750 mg in healthy subjects

Enrollment

223 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, electrocardiograms (ECGs), and clinical laboratory determinations
Body weight will be between 60 and 100 kg, inclusive

Exclusion criteria

Any significant acute or chronic medical illness
Any major surgery within 4 weeks of study drug administration
Smoking more than 10 cigarettes per day
Recent (within 6 months of study drug administration) drug or alcohol abuse.
Positive blood screen for hepatitis C antibody, hepatitis B surface antigen, or Human Immunodeficiency Virus-1, Human Immunodeficiency Virus-2 antibody
History of any significant drug allergy or asthma
Women who are pregnant or breastfeeding and/or unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period