Assessing the Immunogenicity of 2 Subcutaneous Doses of CHS-1701 (Coherus Pegfilgrastim) With 2 Subcutaneous Doses Neulasta®

Inclusion criteria

• Adult male or female of ages 18 to 50 inclusive
• Body weight > 50 kg (110 lb.) and body mass index between 18 and 32 kg/m2 inclusive
• Medically healthy with clinically insignificant findings based on medical history, 12-lead ECG, and physical examination
• Negative urine pregnancy test in women of childbearing potential

Exclusion criteria

• Previous exposure to pegfilgrastim or filgrastim, or known allergy to PEG (polyethylene glycol)
• Chemistry and hematology values outside protocol specified range
• Current or previous cancer, diabetes, or any clinically significant cardiovascular, metabolic, renal, hepatic, gastrointestinal, hematologic, respiratory, dermatological, neurological, psychiatric, or other disorder
• History of chronic or acute respiratory illness within the past 4 weeks
• Positive urine drug or alcohol screen or unwillingness to abstain from alcohol or recreational drugs for the duration of study participation
• No prescription or nonprescription drugs during the study
• Participation in an investigational clinical study within 30 days prior to screening
• Known or suspected allergic reaction to latex