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

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

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®.

Study Overview

• Status: Completed
• Conditions: Immunity, Humoral
• Intervention / Treatment: Drug: CHS-1701; Drug: Pegfilgrastim (Neulasta)

• Study Type: Interventional
• Enrollment (Actual): 303
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CHS-1701; CHS-1701 followed by CHS-1701	Drug: CHS-1701
Active Comparator: Neulasta; Neulasta followed by Neulasta	Drug: Pegfilgrastim (Neulasta); Other Names: Neulasta

What is the study measuring?

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	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

Collaborators and Investigators

• Sponsor: Coherus Biosciences, Inc.
• Investigators: Study Director: Barbara Finck, MD, Coherus Biosciences, Inc.

Publications and helpful links

General Publications

• Civoli F, Finck B, Tang H, Hodge J, O'Kelly H, Vexler V. Biosimilar Pegfilgrastim-cbqv Demonstrated Similar Immunogenicity to Pegfilgrastim in Healthy Subjects Across Three Randomized Clinical Studies. Adv Ther. 2022 Mar;39(3):1230-1246. doi: 10.1007/s12325-021-02024-x. Epub 2022 Jan 16.

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: April 8, 2015
• First Submitted That Met QC Criteria: April 13, 2015
• First Posted (Estimate): April 16, 2015

Study Record Updates

• Last Update Posted (Estimate): January 7, 2016
• Last Update Submitted That Met QC Criteria: January 5, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: CHS-1701-04