NCT02418104

Brief Summary

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®.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
303

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started May 2015

Shorter than P25 for phase_1

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

April 8, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 16, 2015

Completed
15 days until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

January 7, 2016

Status Verified

January 1, 2016

Enrollment Period

7 months

First QC Date

April 8, 2015

Last Update Submit

January 5, 2016

Conditions

Immunity, Humoral

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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

Study Arms (2)

CHS-1701

EXPERIMENTAL

CHS-1701 followed by CHS-1701

Drug: CHS-1701

Neulasta

ACTIVE COMPARATOR

Neulasta followed by Neulasta

Drug: Pegfilgrastim (Neulasta)

Interventions

CHS-1701DRUG
CHS-1701
Pegfilgrastim (Neulasta)DRUG
Also known as: Neulasta
Neulasta

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Adult male or female of ages 18 to 50 inclusive
  • Body weight \> 50 kg (110 lb.) and body mass index between 18 and 32 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, or known allergy to PEG (polyethylene glycol)
  • Chemistry and hematology values outside protocol specified range
  • Current or previous cancer, diabetes, or any clinically significant cardiovascular, metabolic, renal, hepatic, gastrointestinal, hematologic, respiratory, dermatological, neurological, psychiatric, or other disorder
  • History of chronic or acute respiratory illness within the past 4 weeks
  • 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
  • Known or suspected allergic reaction to latex

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Vince & Associates Clinical Research

Overland Park, Kansas, United States

Location

Medpace

Cincinnati, Ohio, United States

Location

ICON

San Antonio, Texas, United States

Location

Spaulding Clinical

West Bend, Wisconsin, United States

Location

Related Publications (1)

  • 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

MeSH Terms

Interventions

pegfilgrastim

Study Officials

  • Barbara Finck, MD

    Coherus Oncology, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 8, 2015

First Posted

April 16, 2015

Study Start

May 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

January 7, 2016

Record last verified: 2016-01

Locations

US(4)