Comparison of the Pharmacokinetic and Pharmacodynamic Biosimilarity of CHS-1701 (Coherus Pegfilgrastim) With Neulasta® (Pegfilgrastim)
Completed · Phase 1
Conditions studied: Bioequivalence
In brief
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®.
Key facts
- Study ID
- NCT02385851
- Run by
- Coherus Oncology, Inc.
- People needed
- 116
- Starts
- 2015-02-01
- Expected to finish
- 2015-07-01
- Last updated by the study team
- 2015-08-13
Who can join
Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.
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
Where it is running
- ICON — San Antonio, Texas, United States
Full record on ClinicalTrials.gov
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