Safety and Pharmacokinetics Study of XOMA 052 in Subjects With Type 2 Diabetes Mellitus

Exclusion Criteria

• •Use of the following medications - Anti-inflammatory therapy other than aspirin ≤ 100 mg/day; Immunosuppressive treatment; Beta 2 and non-selective adrenergic blockers (Note: selective beta 1 blockers are permitted); Thiazolidinediones; Glucagon-like peptide (GLP) agonists including DPP4 inhibitors
• •Change in medication for diabetes within 35 days prior to Day 0, defined as a change in dosing level on 4 or more consecutive days or 7 days in total
• •Fasting C-peptide \< 400 pM (\< 1.20 μg/L)
• •Hemoglobin \< 8.0 g/dL, WBC \< 3.0 X 103/mm3, platelet count \< 125 X 103/mm3, creatinine \> 1.5 mg/dL, AST/ALT \> 2 X ULN, alkaline phosphatase \> 2 X ULN
• •Positive for GAD65 or IA-2 auto-antibodies
• •Known HIV antibody, hepatitis B surface antigen, and/or hepatitis C antibody
• •History of malignancy within 5 years prior to study entry other than carcinoma in situ of the cervix, or adequately treated, non-metastatic squamous or basal cell carcinoma of the skin
• •History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
• •History of tuberculosis, positive PPD test, active atopic disease requiring medication, or asthma
• •Infectious disease - CRP \> 30 mg/L, fever, or infection requiring treatment with antibiotics within 3 weeks prior to Screening; History of recurrent infection or predisposition to infection; Active leg or foot ulcer
• •Immunodeficiency
• •Female subjects who are pregnant, planning to become pregnant during the course of the study, or breast-feeding
• •History or symptoms of a demyelinating disease
• •Clinically significant diabetic macular edema and/or proliferative diabetic retinopathy by history or fundoscopy
• •Receipt of a live (attenuated) vaccine within 3 months prior to Screening
• •Major surgery within 35 days prior to Day 0
• •Participation in an investigational drug or device trial within 30 days prior to Screening
• •Use of a therapeutic monoclonal antibody within 90 days prior to Screening
• •Any condition which, in the opinion of the investigator, would jeopardize the subject's safety following exposure to the study drug