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

Study Overview
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Brief Summary
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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®.

Official Title
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A Randomized, Double-Blind, 2-Period Parallel-Arm Study to Assess the Immunogenicity of 2 Subcutaneous Doses of CHS-1701 (Coherus Pegfilgrastim) With 2 Subcutaneous Doses Neulasta® in Healthy Subjects

Conditions
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Immunity, Humoral

Intervention / Treatment
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* Drug: CHS-1701
* Drug: Pegfilgrastim (Neulasta)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CHS-1701<br>CHS-1701 followed by CHS-1701 | Drug: CHS-1701<br> <br> |
| Active Comparator: Neulasta<br>Neulasta followed by Neulasta | Drug: Pegfilgrastim (Neulasta)<br> <br> * Other names: Neulasta;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the immunogenicity of CHS-1701 compared to Neulasta | The primary objective of this study is to assess the immunogenicity of CHS-1701 compared to Neulasta based on the development of neutralizing antibodies (NAB) and the percent difference in ADA response | 84 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Any potential impact of ADA or NAB on the pharmacokinetic (PK) profile of CHS-1701 using standard parameters (AUC, Cmax, ANCmax, or ANC (AUC0-t) |  | 84 days | 
| Any potential impact of ADA or NAB on pharmacodynamic (PD) response as measured by absolute neutrophil count (ANC) |  | 84 days | 
| Any potential impact of ADA or NAB on safety profile and tolerance of CHS-1701, as assessed by clinical adverse events (AEs), laboratory variables, vital signs, and local injection site reactions (ISRs) |  | 84 days |