A Pharmacokinetic Study of MABp1 in Healthy Volunteers

Inclusion criteria

• Age: ≥18
• Adequate bone marrow function as defined as:

• absolute neutrophil count (neutrophil and bands) of ≥ 1,500/mm3 (≥ 1.5 x 109/L)
• platelet count > 150,000/mm3
• hemoglobin of ≥ 10 g/dL
• Adequate renal function, defined by serum creatinine ≤ 1.5 x lab ULN.
• Adequate hepatic function defined as:

• total bilirubin ≤ 1.5 times lab ULN.
• alanine aminotransferase (ALT) ≤ 2.0 times lab ULN.
• For WOCBP, a negative pregnancy test at screening. For subjects with reproductive potential, a willingness to utilize contraception during the study and for at least 3 months after study completion. Sexually active men must use an accepted method of contraception during the study and for at least 3 months after study completion.
• Signed and dated Institutional Review Board (IRB) approved informed consent before any protocol-specific screening procedures are performed.

Exclusion criteria

• Treatment with any biologicals (including intravenous immunoglobulin) or investigational agents within the last 4 weeks (or 5 half-lives, whichever is longer).
• Uncontrolled or significant cardiovascular disease, including:

• A myocardial infarction within the past 6 months.
• Uncontrolled angina within the past 3 months.
• Congestive heart failure within the past 3 months, defined as New York Heart Association (NYHA) Classes II or higher.
• Uncontrolled hypertension (blood pressure >150 mm Hg systolic and >95 mm Hg diastolic).
• Dementia or altered mental status that would prohibit the understanding or rendering of informed consent.
• Treatment with immunosuppressant agents, including corticosteroids or cyclosporine within the last 4 weeks.
• Serious uncontrolled medical disorders, such as uncontrolled diabetes, active peptic ulcer disease, recent stroke (within 3 months), ongoing congestive heart failure, and any other condition, which in the opinion of the investigator, would put the subject at risk by participation in the protocol.
• History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies.
• Infectious disease:

• CRP >30 mg/L, or infection requiring treatment with antibiotics within 3 weeks prior to Screening,
• Positive HIV, RPR, Hepatitis C antibody, or IGRA
• Immunodeficiency by history.
• Female subjects who are pregnant, planning to become pregnant during the course of the study, or breast-feeding.
• Major surgery within 28 days prior to Day 0.
• WOCBP or men whose sexual partners are WOCBP who are unwilling or unable to use an acceptable method of contraception for at least 1 month prior to randomization, for the duration of the study, and for at least 3 months after the last dose of study medication.
• History of progressive multifocal leukoencephalopathy or other demyelinating disease.