NCT02650973

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
122

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Feb 2016

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 5, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 8, 2016

Completed
24 days until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

August 1, 2016

Status Verified

July 1, 2016

Enrollment Period

4 months

First QC Date

January 5, 2016

Last Update Submit

July 28, 2016

Conditions

Healthy

Keywords

Bioequivalence

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • PK Profile: Cmax

    84 Days

  • PK Profile: tmax

    84 Days

  • PK Profile: AUC0-t

    84 Days

  • PK Profile: 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)

    84 Days

Study Arms (3)

Sequence A

EXPERIMENTAL

3 doses of CHS-1701 or Neulasta, random order

Drug: CHS-1701Drug: Pegfilgrastim

Sequence B

EXPERIMENTAL

3 doses of CHS-1701 or Neulasta, random order

Drug: CHS-1701Drug: Pegfilgrastim

Sequence C

EXPERIMENTAL

3 doses of CHS-1701 or Neulasta, random order

Drug: CHS-1701Drug: Pegfilgrastim

Interventions

CHS-1701DRUG
Sequence ASequence BSequence C
PegfilgrastimDRUG
Also known as: Neulasta
Sequence ASequence BSequence C

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

WCCT

Cypress, California, 90630, United States

Location

Medpace CPU

Cincinnati, Ohio, 45227, United States

Location

ICON

San Antonio, Texas, United States

Location

Spaulding

West Bend, Wisconsin, 53095, United States

Location

Related Publications (2)

  • 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.

    PMID: 35034311DERIVED

  • Finck B, Tang H, Civoli F, Hodge J, O'Kelly H, Vexler V. Pharmacokinetic and Pharmacodynamic Equivalence of Pegfilgrastim-cbqv and Pegfilgrastim in Healthy Subjects. Adv Ther. 2020 Oct;37(10):4291-4307. doi: 10.1007/s12325-020-01459-y. Epub 2020 Aug 13.

    PMID: 32789809DERIVED

MeSH Terms

Interventions

pegfilgrastim

Study Officials

  • Barbara Finck, MD

    Coherus BioSciences

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2016

First Posted

January 8, 2016

Study Start

February 1, 2016

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

August 1, 2016

Record last verified: 2016-07

Locations

US(4)