Open-Label,Single-Arm Pilot Study to Evaluate the Pharmacodynamics, Pharmacokinetics, Safety, and Preliminary Efficacy of CC1004 in Subjects With Severe Plaque Type Psoriasis

Exclusion Criteria

• •Any serious medical condition, laboratory abnormality , or psychiatric illness that would prevent the subject from signing the informed consent form
• •Pregnant or lactating females
• •Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study
• •Current erythrodermic, guttate, or pustular psoriasis
• •Use of medication that is metabolized by the CYP3A4 or CYP2A6 pathways within the 14 days of study medication initiation and/or required use of such medication during study treatment.
• •Drinking or ingesting grapefruits, grapefruit juice or grapefruit containing products within 14 days of study medication initiation
• •Use of topical therapy ( topical steroids, topical vitamin A or D analog preparations, tacrolimus, pimecrolimus, or anthralin) within 14 days of study medications initiation (Exception: Non-medicated emollients and tar shampoo will be allowed)
• •Use of systemic therapy for psoriasis
• •Use or phototherapy within 28 days of study medication initiation
• •Use Humira or Remicade within 3 months of study medication initiation
• •Use of Enbrel within 56 days of study medication initiation
• •Use of Raptiva within 56 days of study medication initiation
• •Use of Amevive within 6 months of study medication initiation
• •Use of any investigational drug within 30 days of study medication initiation or 5 half lives if known
• •History of clinically significant cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic insufficiency disease or other major diseases
• •Clinically significant abnormality on 12-lead ECG at screening
• •Positive HIV, Hepatitis B or Hepatitis C laboratory result at screening
• •History of active tuberculosis within previous 3 years
• •Clinically significant abnormality on the chest x-ray at screening or on CXR taken within 6 months of screening
• •History of positive purified protein derivative (PPD) test at screening
• •History of malignancy within previous five years
• •Evidence of skin conditions at the time of screening visit other than psoriasis that would interfere with evaluations of the effect of study medication on psoriasis