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

Bioequivalence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02385851
• Other study ID #: CHS-1701-03
• Status: Completed
• Phase: Phase 1
• First received: March 2, 2015
• Last updated: August 10, 2015
• Start date: February 2015
• Est. completion date: July 2015

Study information

• Verified date: August 2015
• Source: Coherus Biosciences, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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®.

Description:

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®.

After screening, eligible subjects will be randomly assigned to 1 of 2 treatment sequences; CHS-1701 followed by Neulasta® (Sequence A) or Neulasta® followed by CHS-1701, Sequence B). Treatments will be spaced by a minimum of 6 weeks apart (but no more than 8 weeks). Subjects will be admitted to the Clinical Pharmacology Unit (CPU) on Day -1 (Period 1) and will be confined through Hour 96 postdose (a total of approximately 4.5 days and 5 nights). Blood samples will be collected at specified time points postdose for plasma PK and PD measurements and the subjects will be closely monitored for safety. Following discharge on the morning of Day 5 (Period 1) subjects will return to the clinic for additional PK, PD and safety follow up--daily through Day 9 and at stated interval time points thereafter.

The single dose of the alternate blinded study drug will be given after 6 (but no more than 8) weeks of observation and washout and the above procedures will be repeated (Period 2). A Follow up Visit will take place 41 (±1) days after the second dose.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator)

Related Conditions & MeSH terms

• Bioequivalence

Intervention

Drug:
• CHS-1701

• Pegfilgrastim

Locations

Country	Name	City	State
United States	ICON	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Coherus Biosciences, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biosimilarity as measured by absolute neutrophil count (ANC)	The primary objective of this study is to assess the biosimilarity of CHS-1701 with Neulasta® based on the pharmacokinetics (PK) of pegfilgrastim and the pharmacodynamic (PD) response as measured by absolute neutrophil count (ANC).	84 Days	No
Secondary	PK Profile: Cmax (tmax), AUC0-t, and t1/2	Characterization of the PK profile of CHS-1701 using standard parameters (Cmax (tmax), AUC0-t, and t1/2)	84 Days	No
Secondary	Safety Profile as assessed by clinical adverse events (AEs), laboratory variables, vital signs, incidence of antidrug antibodies (ADAs), and local injection site reactions (ISRs).	Characterization of the safety profile and tolerance of CHS-1701, as assessed by clinical adverse events (AEs), laboratory variables, vital signs, incidence of antidrug antibodies (ADAs), and local injection site reactions (ISRs).	84 Days	Yes