Study to Assess the Pharmacokinetic and Pharmacodynamic Bioequivalence of CHS-1701 With Neulasta

• Status: Completed
• Trial end date: 2016-06-01
• Target enrollment: 0
• Participant gender: All

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.

• 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 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