Status:
COMPLETED
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
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Psoriasis Vulgaris
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
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. Safet...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
November 1 1995
Trial Type :
INTERVENTIONAL
End Date :
June 1 1996
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00277225
Start Date
November 1 1995
End Date
June 1 1996
Last Update
April 13 2011
Active Locations (1)
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1
California Clinical Trials Medical Group
Beverly Hills, California, United States