Comparability DE vs CD-CHO1

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-09-30

Study Completion Date

2002-12-31

Brief Summary

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Study to Compare the Pharmacokinetics of CD-CHO1 Process BMS-188667 to DE Process BMS-188667 in Healthy Subjects

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Detailed Description

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Conditions

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Healthy Subjects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Abatacept

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Signed consent form
* Healthy subjects as determined by good health as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs and clinical laboratory determinations.
* Body weight for all subjects will be \<- 100 kg.
* body Mass Index (BMI) of 18-30 kg/m2 inclusive; BMI = weight (kg)/\[height (m)\]2
* Men and women (not nursing, not prgnant), who are at least 18 years of age. Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study for at least 4 weeks before and for up to 10 weeks after the infusion of BMS-188667 in such a manner that the risk of pregnancy is minimized.

Exclusion Criteria

* WOCBP and males who are unwilling or unable to use an acceptable method to avoid pregnancy for up to 10 weeks after he infusion of BMS-1886678. WOCBP must also be using an acceptable method of contraception for at least 1 month before dosing.
* Women who are pregnant ore breast-feeding.
* Women with positive pregnanacy tes on enrollment or prior to study drug administration.
* History or current evidence of any signiicant acute or chroinic medical illness

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes