Bioavailability of ASKP1240 in Healthy Subjects After Intravenous and Subcutaneous Administration of ASKP1240

Inclusion Criteria:

• The subject weighs at least 50 kg, and has a body mass index (BMI) of 18 to 32 kg/m2, inclusive
• The female subject must be a) at least two years post-menopausal (defined as at least 2 years without menses) at Screening and a confirmatory follicle stimulating hormone (FSH) level of >40 U/L at Screening) or b) surgically sterile (with documentation provided by a healthcare professional) and not pregnant or lactating at Screening and Day -1. c) If child bearing potential, the subject will be required to use adequate contraception consisting of two forms of birth control (one of which must be a barrier method) until the end of the study or for 90 days after final study drug administration, whichever is longer
• The male subject agrees to sexual abstinence, is surgically sterile (with documentation provided by a healthcare professional), or is using a medically acceptable method (e.g. spermicide and diaphragm, or spermicide and condom) to prevent pregnancy and agrees to continue using this method until the end of study
• Male subject agrees to no sperm donation until the end of the study or for 90 days after the conclusion of study drug administration, whichever is longer

Exclusion Criteria:

• The subject has a history or evidence of any clinically significant (as determined by the Investigator) cardiovascular, endocrine, ophthalmologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary (including asthma or emphysema), neurologic, dermatologic, psychiatric, renal, and/or other major disease or malignancy (excluding non-melanoma skin cancer)
• The subject has a history of severe allergic or anaphylactic reactions
• The subject has a history of consuming more than 14 units of alcoholic beverages (one unit is 12 ounces of beer, 4 ounces of wine or 1 ounce of spirits) per week on average within 6 months prior to Screening or has a history of alcoholism or drug/chemical/substance abuse within past 2 years prior to Screening or the subject tests positive at Screening or Day -1 for alcohol or drugs of abuse (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, and opiates)
• The subject has/had a symptomatic, viral, bacterial or fungal (non-cutaneous) infection within 1 week prior to clinic check in on Day -1
• The subject has a history of thromboembolic or vascular disease especially deep vein thrombosis or pulmonary embolism
• The subject has used any tobacco-containing products, nicotine or nicotine-containing products in the past 6 months prior to Screening
• The subject has a supine mean systolic blood pressure < 90 or > 160 mmHg and a mean diastolic blood pressure < 50 or > 90 mmHg, or mean heart rate > 100 beats per minute (bpm), either at Screening or Day -1 (measurements taken in triplicate after subject has been resting in a supine position for a minimum of 5 minutes)
• The subject is known to be positive for human immunodeficiency virus (HIV) antibody
• The subject has a positive test for hepatitis C virus (HCV) antibody, hepatitis B surface antigen (HBsAg), or hepatitis B core antibody at Screening

• The subject has the following at Screening or Day -1:

  1. White blood cell count (WBC) is < 3.5 (109/L) or > upper limit of normal
  2. Absolute neutrophil count (ANC) is < 1.5 (109/L) or > upper limit of normal
  3. Platelet count (PLT) is outside the normal limit
  4. Serum creatinine, total bilirubin, alanine aminotransferase (ALT), or aspartate aminotransferase (AST) are > upper limit of normal
  5. Creatine phosphokinase (CPK) is > 2x times upper limit of normal
  6. International normalized ratio (INR) is > upper limit of normal
  7. Remaining laboratory tests are outside the normal limits and considered by the investigator to be clinically significant with regard to the remaining per-protocol laboratory tests
• The subject has received any vaccine within 60 days prior to Day -1
• The subject has received any systemic immunosuppressant agent (e.g., methotrexate) within 6 months prior to Day -1
• The subject has received any systemic steroid within 2 months prior to Day -1
• The subject has received any antibody or therapeutic biologic product within 6 months prior to Day -1
• The subject has used prescription or non-prescription medications (excluding acetaminophen [up to 2 g/day maximum], stable hormone replacement therapy [HRT], and/or nasal steroids/steroid inhaler), or complementary and alternative medicines (CAM) within 14 days or 5 half lives (whichever is longer) prior to Day -1
• The subject has a positive TB skin test, Quantiferon Gold test or T-SPOT test® at Screening
• The subject has participated in a previous ASKP1240 study