Phase 1 Study Evaluating the Safety, Pharmacokinetics and Pharmacodynamics of PRTX-100 in Healthy Adult Volunteers

Inclusion Criteria: * Able to provide written, informed consent * Subjects in good health as determined by medical history, physical exam, standard safety laboratory tests, electrocardiogram (ECG) and vital signs * Body Mass Index (BMI) within the range of 18.5-32 kg/m2 * Normotensive, defined as systolic blood pressure less than or equal to 150 mmHg and diastolic blood pressure less than or equal to 90 mmHg Exclusion Criteria: * Positive IgE anti-SpA titer on screening visit * Male and female subjects unwilling to use acceptable forms of birth control throughout the study (acceptable forms include hormonal contraceptives used for at least 2 months prior to the screening visit, condom plus spermicide, cervical cap plus spermicide, diaphragm plus spermicide, or intrauterine device plus spermicide) * Pregnant (β-hCG serum pregnancy test positive) or nursing (lactating) female subjects * Clinically significant history or evidence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological, immunological, or psychiatric disorder(s), as determined by the investigator or designee * Past medical history of deep venous thrombosis or thromboembolic disease, stroke, myocardial infarction, recurrent fetal loss, or prior diagnosis of Protein C deficiency or of factor V Leyden genotype * Past history of vasculitis or autoimmune disease * Clinical signs or symptoms of acute or resolving viral or bacterial infection * History of atopic dermatitis or asthma * History of current hepatitis or carriers of hepatitis B and/or hepatitis C (Hepatitis B surface antigen \[HbsAg\] positive or IgM antibodies to Hepatitis C \[anti Hepatitis C IgM\]). * History of AIDS or determined HIV seropositive at screening * Any disorder that would interfere with the absorption, distribution, metabolism, or excretion of drugs * Clinically significant abnormalities in screening laboratory tests (hematology, chemistry, urinalysis) * Positive urine drug test at screening or baseline (e.g., cocaine, amphetamines, barbiturates, opiates, benzodiazepines, etc.) * Positive blood test for ethanol at screening or baseline * Use of dietary supplements or prescription (with the exception of hormonal contraceptives), herbal, and over-the-counter medication(s) (with the exception of acetaminophen less than or equal to 1000 mg/day) within the 10 days prior to study Day 1 * Unable to refrain from tobacco or nicotine product use during the period of study confinement * Donation of blood or plasma within 30 days prior to dosing * Use of (an) investigational drug(s) within the 30 days or 5 half-lives (whichever is longer) prior to Day 1