Study to Assess the Pharmacokinetic and Pharmacodynamic Bioequivalence of CHS-1701 With Neulasta

Study Overview
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Brief Summary
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This is a randomized, single-blind, 3-period crossover study in healthy subjects to assess PK, PD, and safety (including immunogenicity) of a single 6mg subcutaneous injection of CHS-1701 (Coherus pegfligrastim) or 6mg SC dose of Neulasta (pegfilgrastim) given during each period.

Detailed Description
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This is a randomized, single-blind, 3-period crossover study in healthy subjects to assess PK, PD, and safety (including immunogenicity) of a single 6mg subcutaneous injection of CHS-1701 or 6mg SC dose of Neulasta given during each period. The screening period may occur up to 28 days prior to the confinement period. After screening, eligible subjects will be randomly assigned to one of three possible treatment sequences. Treatments will be spaced by not less than 28 days.

Official Title
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A Randomized, Single-Blind, Crossover Study to Assess the Pharmacokinetic and Pharmacodynamic Bioequivalence of CHS-1701 (Coherus Pegfilgrastim) With Neulasta® in Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: CHS-1701
* Drug: Pegfilgrastim


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult male or female of ages 18 to 45 inclusive Body weight > 50 kg (110 lb.) and body mass index between 18 and 28 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 Current or previous cancer, diabetes, or any clinically significant cardiovascular, metabolic, endocrine, renal, hepatic, gastrointestinal, hematologic, respiratory, dermatological, neurological, gynecologic, psychiatric, or other disorder History of chronic or acute respiratory illness within the past 3 months 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 History of known clinically significant drug and/or food allergies, including allergic reaction to latex

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 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: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequence A<br>3 doses of CHS-1701 or Neulasta, random order | Drug: CHS-1701<br> <br> Drug: Pegfilgrastim<br> <br> * Other names: Neulasta;|
| Experimental: Sequence B<br>3 doses of CHS-1701 or Neulasta, random order | Drug: CHS-1701<br> <br> Drug: Pegfilgrastim<br> <br> * Other names: Neulasta;|
| Experimental: Sequence C<br>3 doses of CHS-1701 or Neulasta, random order | Drug: CHS-1701<br> <br> Drug: Pegfilgrastim<br> <br> * Other names: Neulasta;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence as measured by PK and PD | The primary objective of this study is to assess the bioequivalence of CHS-1701 with Neulasta® based on the pharmacokinetics (PK) of pegfilgrastim and the pharmacodynamic (PD) response as measured by absolute neutrophil count (ANC) | 84 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK Profile: Cmax | Characterization of the PK profile of CHS-1701 using standard parameters of maximum plasma concentration (Cmax) | 84 Days | 
| PK Profile: tmax | Characterization of the PK profile of CHS-1701 using standard parameters of time to maximum plasma concentration (tmax) | 84 Days | 
| PK Profile: AUC0-t | Characterization of the PK profile of CHS-1701 using standard parameters of area under the plasma concentration versus time curve calculated from 0 to the last measurable observation (AUC0-t) | 84 Days | 
| PK Profile: t1/2 | Characterization of the PK profile of CHS-1701 using standard parameters of terminal elimination half-life (t1/2) | 84 Days | 
| Safety Profile as assessed by clinical adverse events (AEs), laboratory variables, vital signs, incidence of antidrug antibodies (ADAs), and local injection site reactions (ISRs) | Characterization of the safety profile and tolerance of CHS-1701, as assessed by clinical adverse events (AEs), laboratory variables, vital signs, incidence of antidrug antibodies (ADAs), and local injection site reactions (ISRs). | 84 Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bioequivalence