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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

223 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2012-02-29

Brief Summary

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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

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Detailed Description

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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

Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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Abatacept (BMS-188667) manufactured at Lonza, NH facility

Group Type ACTIVE_COMPARATOR

Abatacept (BMS-188667)

Intervention Type BIOLOGICAL

Solution for injection, Intravenous, 750 mg, Single dose, 1 day,

Abatacept (BMS-188667) manufactured at Devens, MA facility

Group Type EXPERIMENTAL

Abatacept (BMS-188667)

Intervention Type BIOLOGICAL

Solution for injection, Intravenous, 750 mg, Single dose, 1 day,

Interventions

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Abatacept (BMS-188667)

Solution for injection, Intravenous, 750 mg, Single dose, 1 day,

Intervention Type BIOLOGICAL

Other Intervention Names

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BMS-188667

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes