NCT02385851

Brief 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®.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
116

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Feb 2015

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

February 1, 2015

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

March 2, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 11, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

August 13, 2015

Status Verified

August 1, 2015

Enrollment Period

5 months

First QC Date

March 2, 2015

Last Update Submit

August 10, 2015

Conditions

Bioequivalence

Outcome Measures

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).

    84 Days

Secondary Outcomes (2)

  • PK Profile: Cmax (tmax), AUC0-t, and 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 (2)

CHS-1701/Neulasta

EXPERIMENTAL

CHS-1701 followed by Neulasta (crossover)

Drug: CHS-1701Drug: Pegfilgrastim

Neulasta/CHS-1701

EXPERIMENTAL

Neulasta followed by CHS-1701 (crossover)

Drug: CHS-1701Drug: Pegfilgrastim

Interventions

CHS-1701DRUG
CHS-1701/NeulastaNeulasta/CHS-1701
PegfilgrastimDRUG
Also known as: Neulasta
CHS-1701/NeulastaNeulasta/CHS-1701

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 (1)

ICON

San Antonio, Texas, 78209, 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
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2015

First Posted

March 11, 2015

Study Start

February 1, 2015

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

August 13, 2015

Record last verified: 2015-08

Locations

US(1)