Comparison of the Pharmacokinetic and Pharmacodynamic Biosimilarity of CHS-1701 (Coherus Pegfilgrastim) With Neulasta® (Pegfilgrastim)

Coherus BioSciences

Status and phase: Completed; Phase 1

Conditions: Bioequivalence

Treatments: Drug: CHS-1701; Drug: Pegfilgrastim

Study type: Interventional

Funder types: Industry

Identifiers

NCT02385851

CHS-1701-03

Details and patient eligibility

About

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®.

Full description

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®.

After screening, eligible subjects will be randomly assigned to 1 of 2 treatment sequences; CHS-1701 followed by Neulasta® (Sequence A) or Neulasta® followed by CHS-1701, Sequence B). Treatments will be spaced by a minimum of 6 weeks apart (but no more than 8 weeks). Subjects will be admitted to the Clinical Pharmacology Unit (CPU) on Day -1 (Period 1) and will be confined through Hour 96 postdose (a total of approximately 4.5 days and 5 nights). Blood samples will be collected at specified time points postdose for plasma PK and PD measurements and the subjects will be closely monitored for safety. Following discharge on the morning of Day 5 (Period 1) subjects will return to the clinic for additional PK, PD and safety follow up--daily through Day 9 and at stated interval time points thereafter.

The single dose of the alternate blinded study drug will be given after 6 (but no more than 8) weeks of observation and washout and the above procedures will be repeated (Period 2). A Follow up Visit will take place 41 (±1) days after the second dose.

Enrollment: 116 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Adult male or female of ages 18 to 50 inclusive
2. Body weight > 50 kg (110 lb.) and body mass index between 18 and 32 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, or known allergy to PEG (polyethylene glycol)
2. Chemistry and hematology values outside protocol specified range
3. Current or previous cancer, diabetes, or any clinically significant cardiovascular, metabolic, renal, hepatic, gastrointestinal, hematologic, respiratory, dermatological, neurological, psychiatric, or other disorder
4. History of chronic or acute respiratory illness within the past 4 weeks
5. Positive urine drug or alcohol screen or unwillingness to abstain from alcohol or recreational drugs for the duration of study participation
6. No prescription or nonprescription drugs during the study
7. Participation in an investigational clinical study within 30 days prior to screening
8. Known or suspected allergic reaction to latex

Trial design

116 participants in 2 patient groups

CHS-1701/Neulasta

Experimental group

Description:

CHS-1701 followed by Neulasta (crossover)

Treatment:

Drug: Pegfilgrastim

Drug: CHS-1701

Neulasta/CHS-1701

Experimental group

Description:

Neulasta followed by CHS-1701 (crossover)

Treatment:

Drug: Pegfilgrastim

Drug: CHS-1701