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



Status:Recruiting
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 45
Updated:4/21/2016
Start Date:February 2016
End Date:May 2016
Contact:Regan Burns
Email:rburns@coherus.com
Phone:6506493530

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A Randomized, Single-Blind, Crossover Study to Assess the Pharmacokinetic and Pharmacodynamic Bioequivalence of CHS-1701 (Coherus Pegfilgrastim) With Neulasta® in Healthy Subjects

This is a randomized, single-blind, single-dose, 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.

This is a randomized, single-blind, single-dose, crossover study in healthy subjects to
assess PK, PD, and safety (including immunogenicity) of a single 6mg subcutaneous injection
of CHS-1701 or 6mg SC dose of Neulasta given during each period.

The screening period may occur up to 28 days prior to the confinement period. After
screening, eligible subjects will be randomly assigned to one of three possible treatment
sequences; CHS-1701 followed by Neulasta, Neulasta followed by CHS-1701, or Neulasta
followed by Neulasta. Treatments will be spaced by not less than 28 days and not greater
than 56 days.

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
We found this trial at
4
sites
West Bend, Wisconsin 53095
Principal Investigator: Carlos Sanabria
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West Bend, WI
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Cincinnati, Ohio
Principal Investigator: Leela Vrishabhendra
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Cincinnati, OH
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Cypress, California 90630
Principal Investigator: Evelyn Darius
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Cypress, CA
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San Antonio, Texas 78209
Principal Investigator: Dennis Ruff
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San Antonio, TX
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