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CompletedNCT02385851Updated Aug 13, 2015

Comparison of the Pharmacokinetic and Pharmacodynamic Biosimilarity of CHS-1701 (Coherus Pegfilgrastim) With Neulasta® (Pegfilgrastim)

A Phase 1 interventional study of CHS-1701 and Pegfilgrastim in Bioequivalence, sponsored by Coherus Oncology, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-08-13.

Sponsored by Coherus Oncology, Inc. · Phase 1 and Interventional

Phase
Phase 1
Study type
Interventional
Enrollment
116
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study summary

This is a randomized, double-blind, single-dose, 2-period crossover study in healthy subjects to assess PK, PD, and safety (including immunogenicity) of a single 6 mg subcutaneous (SC) injection of CHS-1701 compared with a single 6 mg SC dose of Neulasta®.

Read the detailed description

This is a randomized, double-blind, single-dose, 2-period crossover study in healthy subjects to assess PK, PD, and safety (including immunogenicity) of a single 6 mg subcutaneous (SC) injection of CHS-1701 compared with a single 6 mg SC dose of Neulasta®.

After screening, eligible subjects will be randomly assigned to 1 of 2 treatment sequences; CHS-1701 followed by Neulasta® (Sequence A) or Neulasta® followed by CHS-1701, Sequence B). Treatments will be spaced by a minimum of 6 weeks apart (but no more than 8 weeks). Subjects will be admitted to the Clinical Pharmacology Unit (CPU) on Day -1 (Period 1) and will be confined through Hour 96 postdose (a total of approximately 4.5 days and 5 nights). Blood samples will be collected at specified time points postdose for plasma PK and PD measurements and the subjects will be closely monitored for safety. Following discharge on the morning of Day 5 (Period 1) subjects will return to the clinic for additional PK, PD and safety follow up--daily through Day 9 and at stated interval time points thereafter.

The single dose of the alternate blinded study drug will be given after 6 (but no more than 8) weeks of observation and washout and the above procedures will be repeated (Period 2). A Follow up Visit will take place 41 (±1) days after the second dose.

02

Conditions studied

  • Bioequivalence
03

In context

Lead sponsor

Coherus Oncology, Inc. is the lead sponsor of 7 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 1
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
116 participants (actual)

Study arms

  • Experimental
    CHS-1701/Neulasta

    CHS-1701 followed by Neulasta (crossover)

    Drug: CHS-1701 · Drug: Pegfilgrastim

  • Experimental
    Neulasta/CHS-1701

    Neulasta followed by CHS-1701 (crossover)

    Drug: CHS-1701 · Drug: Pegfilgrastim

Interventions

06

What researchers measure

Primary outcomes

  1. Biosimilarity as measured by absolute neutrophil count (ANC)

    The primary objective of this study is to assess the biosimilarity of CHS-1701 with Neulasta® based on the pharmacokinetics (PK) of pegfilgrastim and the pharmacodynamic (PD) response as measured by absolute neutrophil count (ANC).

    Time frame: 84 Days

Secondary outcomes

  1. PK Profile: Cmax (tmax), AUC0-t, and t1/2

    Characterization of the PK profile of CHS-1701 using standard parameters (Cmax (tmax), AUC0-t, and t1/2)

    Time frame: 84 Days

  2. 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).

    Time frame: 84 Days

07

Study locations

1 site
  • ICON
    San Antonio, Texas 78209, United States
08

References and documents

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. PubMed 35034311 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Feb 2015, a primary completion of Jul 2015 and a completion of Jul 2015. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 2, 2015
First posted
Mar 11, 2015
Start
Feb 2015
Primary completionActual
Jul 2015
CompletionActual
Jul 2015
Last update
Aug 13, 2015
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 13, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02385851
Lead sponsor
Coherus Oncology, Inc.
Responsible party
Sponsor
First posted
Mar 11, 2015
Start date
Feb 2015
Primary completion
Jul 2015
Completion
Jul 2015
Last update
Aug 13, 2015

Study contacts

Barbara Finck, MD
study director · Coherus Oncology, Inc.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Pegfilgrastim

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Coherus Oncology, Inc.

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