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

Sponsor
Coherus Biosciences, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT02650973
Collaborator
(none)
122
Enrollment
4
Locations
3
Arms
4
Duration (Months)
30.5
Patients Per Site
7.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed Description

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
122 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Participant)
Official Title:
A Randomized, Single-Blind, Crossover Study to Assess the Pharmacokinetic and Pharmacodynamic Bioequivalence of CHS-1701 (Coherus Pegfilgrastim) With Neulasta® in Healthy Subjects
Study Start Date :
Feb 1, 2016
Actual Primary Completion Date :
Jun 1, 2016
Actual Study Completion Date :
Jun 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: Sequence A

3 doses of CHS-1701 or Neulasta, random order

Drug: CHS-1701

Drug: Pegfilgrastim
Other Names:
  • Neulasta

    		•
    Experimental: Sequence B

    3 doses of CHS-1701 or Neulasta, random order

    Drug: CHS-1701

    Drug: Pegfilgrastim
    Other Names:
  • Neulasta

    		•
    Experimental: Sequence C

    3 doses of CHS-1701 or Neulasta, random order

    Drug: CHS-1701

    Drug: Pegfilgrastim
    Other Names:
  • Neulasta

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Bioequivalence as measured by PK and PD [84 Days]

      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)

    Secondary Outcome Measures

    1. PK Profile: Cmax [84 Days]

      Characterization of the PK profile of CHS-1701 using standard parameters of maximum plasma concentration (Cmax)

    2. PK Profile: tmax [84 Days]

      Characterization of the PK profile of CHS-1701 using standard parameters of time to maximum plasma concentration (tmax)

    3. PK Profile: AUC0-t [84 Days]

      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)

    4. PK Profile: t1/2 [84 Days]

      Characterization of the PK profile of CHS-1701 using standard parameters of terminal elimination half-life (t1/2)

    5. Safety Profile as assessed by clinical adverse events (AEs), laboratory variables, vital signs, incidence of antidrug antibodies (ADAs), and local injection site reactions (ISRs) [84 Days]

      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).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    1. Adult male or female of ages 18 to 45 inclusive

    2. Body weight > 50 kg (110 lb.) and body mass index between 18 and 28 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

    2. Current or previous cancer, diabetes, or any clinically significant cardiovascular, metabolic, endocrine, renal, hepatic, gastrointestinal, hematologic, respiratory, dermatological, neurological, gynecologic, psychiatric, or other disorder

    3. History of chronic or acute respiratory illness within the past 3 months

    4. Positive urine drug or alcohol screen or unwillingness to abstain from alcohol or recreational drugs for the duration of study participation

    5. No prescription or nonprescription drugs during the study

    6. Participation in an investigational clinical study within 30 days prior to screening

    7. History of known clinically significant drug and/or food allergies, including allergic reaction to latex

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 WCCT Cypress California United States 90630
    2 Medpace CPU Cincinnati Ohio United States 45227
    3 ICON San Antonio Texas United States
    4 Spaulding West Bend Wisconsin United States 53095

    Sponsors and Collaborators

    • Coherus Biosciences, Inc.

    Investigators

    • Study Director: Barbara Finck, MD, Coherus BioSciences

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Coherus Biosciences, Inc.
    ClinicalTrials.gov Identifier:
    NCT02650973
    Other Study ID Numbers:
    • CHS-1701-05
    First Posted:
    Jan 8, 2016
    Last Update Posted:
    Aug 1, 2016
    Last Verified:
    Jul 1, 2016
    Keywords provided by Coherus Biosciences, Inc.
    Bioequivalence

    Study Results

    No Results Posted as of Aug 1, 2016