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

July 28, 2016 updated by: Coherus Biosciences, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

122

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Cypress, California, United States, 90630
        • WCCT
    • Ohio
      • Cincinnati, Ohio, United States, 45227
        • Medpace CPU
    • Texas
      • San Antonio, Texas, United States
        • ICON
    • Wisconsin
      • West Bend, Wisconsin, United States, 53095
        • Spaulding

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sequence A
3 doses of CHS-1701 or Neulasta, random order
Drug: Pegfilgrastim
Other Names:
  • Neulasta
Drug: CHS-1701
Experimental: Sequence B
3 doses of CHS-1701 or Neulasta, random order
Drug: Pegfilgrastim
Other Names:
  • Neulasta
Drug: CHS-1701
Experimental: Sequence C
3 doses of CHS-1701 or Neulasta, random order
Drug: Pegfilgrastim
Other Names:
  • Neulasta
Drug: CHS-1701

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bioequivalence as measured by PK and PD
Time Frame: 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)
84 Days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PK Profile: Cmax
Time Frame: 84 Days
Characterization of the PK profile of CHS-1701 using standard parameters of maximum plasma concentration (Cmax)
84 Days
PK Profile: tmax
Time Frame: 84 Days
Characterization of the PK profile of CHS-1701 using standard parameters of time to maximum plasma concentration (tmax)
84 Days
PK Profile: AUC0-t
Time Frame: 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)
84 Days
PK Profile: t1/2
Time Frame: 84 Days
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)
Time Frame: 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).
84 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Coherus Biosciences, Inc.

Investigators

  • Study Director: Barbara Finck, MD, Coherus BioSciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

January 5, 2016

First Submitted That Met QC Criteria

January 7, 2016

First Posted (Estimate)

January 8, 2016

Study Record Updates

Last Update Posted (Estimate)

August 1, 2016

Last Update Submitted That Met QC Criteria

July 28, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CHS-1701-05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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