Study to Assess the Pharmacokinetic and Pharmacodynamic Bioequivalence of CHS-1701 With Neulasta
Completed · Phase 1
Conditions studied: Healthy
In brief
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.
Key facts
- Study ID
- NCT02650973
- Run by
- Coherus Oncology, Inc.
- People needed
- 122
- Starts
- 2016-02-01
- Expected to finish
- 2016-06-01
- Last updated by the study team
- 2016-08-01
Who can join
Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Adult male or female of ages 18 to 45 inclusive
- Body weight > 50 kg (110 lb.) and body mass index between 18 and 28 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
- Current or previous cancer, diabetes, or any clinically significant cardiovascular, metabolic, endocrine, renal, hepatic, gastrointestinal, hematologic, respiratory, dermatological, neurological, gynecologic, psychiatric, or other disorder
- History of chronic or acute respiratory illness within the past 3 months
- 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
- History of known clinically significant drug and/or food allergies, including allergic reaction to latex
Where it is running
- WCCT — Cypress, California, United States
- Medpace CPU — Cincinnati, Ohio, United States
- ICON — San Antonio, Texas, United States
- Spaulding — West Bend, Wisconsin, United States
Full record on ClinicalTrials.gov
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