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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02385851
Other study ID # CHS-1701-03
Secondary ID
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


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
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