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

• Status: Completed
• Trial end date: 2015-07-01
• Target enrollment: 0
• Participant gender: All

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®.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Coherus Biosciences, Inc.

Criteria

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