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

Completed · Phase 1

Conditions studied: Immunity, Humoral

In brief

This is a randomized, double-blind, 2-period parallel study in healthy subjects to assess immunogenicity and safety of two sequential 6 mg subcutaneous (SC) injections of CHS-1701 compared with two sequential 6 mg SC injections of Neulasta®.

Key facts

Study ID

NCT02418104

Run by

Coherus Oncology, Inc.

People needed

303

Starts

2015-05-01

Expected to finish

2015-12-01

Last updated by the study team

2016-01-07

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Vince & Associates Clinical Research — Overland Park, Kansas, United States
• Medpace — Cincinnati, Ohio, United States
• ICON — San Antonio, Texas, United States
• Spaulding Clinical — West Bend, Wisconsin, United States

Full record on ClinicalTrials.gov

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