1. Any serious medical condition or psychiatric illness that would prevent, (as judged by the treating physician) the subject from signing the informed consent form or 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.
2. Pregnant or lactating.
3. Known history of human immunodeficiency virus (HIV), hepatitis C, or hepatitis B.
4. History or presence of any form of cancer within the 3 years prior to enrollment, with the exception of excised basal cell or squamous cell carcinoma of the skin, or cervical carcinoma in situ or breast carcinoma in situ that has been excised or resected completely and is without evidence of local recurrence or metastasis.
5. Participation in an investigational drug or device trial within 2 weeks prior to study Day 1 or within 5 times the half-life of the investigational agent in the other clinical study, if known.
6. Use of any cytotoxic chemotherapeutic agents (eg, hydroxyurea), corticosteroids (prednisone ≤ 10 mg/day or corticosteroid equivalent is allowed), or immunodulators (eg, thalidomide) within 2 weeks and interferon use within 4 weeks prior to study Day 1.
7. Symptomatic congestive heart failure (New York Heart Association Classification > Class II), unstable angina, or unstable cardiac arrhythmia requiring medication.
8. History of surgery within 2 weeks prior to enrollment or anticipated surgery during the study period.
9. Any other condition that might reduce the chance of obtaining data required by the protocol or that might compromise the ability to give truly informed consent.