CClinicalTrials.gg
CompletedNCT00277199Updated Apr 13, 2011

Comparability DE vs CD-CHO1

A Phase 1 interventional study of Abatacept in Healthy Subjects, sponsored by Bristol-Myers Squibb. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-04-13.

Sponsored by Bristol-Myers Squibb · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Healthy Subjects
03

In context

Lead sponsor

Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.

Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants

Interventions

  • DrugAbatacept
06

What researchers measure

Primary outcomes

  1. To test pharmacokinetics

Secondary outcomes

  1. To test Safety and immunogenicity

07

Study locations

1 site
  • Inveresk Clinical Research
    Edinburgh, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 13, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00277199
Lead sponsor
Bristol-Myers Squibb
First posted
Jan 16, 2006
Start date
Sep 2002
Primary completion
Dec 2002
Completion
Dec 2002
Last update
Apr 13, 2011

Study contacts

Bristol-Myers Squibb
study director · Bristol-Myers Squibb
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2011. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion