A Study to Assess the Pharmacokinetics, Immunogenicity and Safety of Escalating Doses of BMS-188667 Given as a Single Intravenous Infusion to Patients With Psoriasis Vulgaris

Completed · Phase 1

Conditions studied: Psoriasis Vulgaris

In brief

The purpose of this protocol is to determine the single-dose pharmacokinetics and immunogicity of BMS-188667 administered as a 1 hour intravenous infusion with extended pharmacokinetic sampling. Safety of all subjects will be assessed in a double blind fashion through the inclusion of placebo controls at each dose level.

Key facts

Study ID

NCT00277225

Run by

Bristol-Myers Squibb

People needed

32

Starts

1995-11-01

Expected to finish

1996-06-01

Last updated by the study team

2011-04-13

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects required to have a know diagnosis of psoriasis vulgaris involving 5-49% of total body surface area (BSA) for at least six months prior to randomization.
• Subjects clinically insignificant abnormal laboratory or ECG test results who were otherwise healthy and met all remaining eligibility criteria.

You may not qualify if…

• Evidence of active bacterial or viral infections at the time of enrollment, including any history of or clinical evidence of infection with Human Immunodeficiency virus (HIV) Hepatitis B or Hepatitis C.
• Any underlying metabolic, hematologic, pulmonary, cardiac, renal hepatic, infectious, psychiatric or gastrointestional condition, which in the opinion of the investigator, placed the subject at unacceptable risk from participation in a study with potentially immunosuppresive therapy.

Where it is running

• California Clinical Trials Medical Group — Beverly Hills, California, United States

Full record on ClinicalTrials.gov

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