Clinical trial NCT02650973: Study to Assess the Pharmacokinetic and Pharmacodynamic Bioequivalence of CHS-1701 With Neulasta
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Bioequivalence
Lead sponsor: Coherus Biosciences, Inc.
Sponsor class: INDUSTRY
First posted: 2016-01-08
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Bioequivalence as measured by PK and PD
timeFrame: 84 Days
Secondary outcomes:
measure: PK Profile: Cmax
timeFrame: 84 Days
measure: PK Profile: tmax
timeFrame: 84 Days
measure: PK Profile: AUC0-t
timeFrame: 84 Days
measure: PK Profile: t1/2
timeFrame: 84 Days
measure: Safety Profile as assessed by clinical adverse events (AEs), laboratory variables, vital signs, incidence of antidrug antibodies (ADAs), and local injection site reactions (ISRs)
timeFrame: 84 Days
Other outcomes:
Locations:
city: Cypress
country: United States
facility: WCCT
state: California
city: Cincinnati
country: United States
facility: Medpace CPU
state: Ohio
city: San Antonio
country: United States
facility: ICON
state: Texas
city: West Bend
country: United States
facility: Spaulding
state: Wisconsin
Study officials:
affiliation: Coherus BioSciences
name: Barbara Finck, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.