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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: CHS-1701; Drug: Pegfilgrastim

• Registration Number: NCT02650973
• Lead Sponsor: Coherus Biosciences, Inc.

Brief 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.

Detailed Description

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 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. Treatments will be spaced by not less than 28 days.

Study Timeline

• Study First Submitted: 2016-01-05
• Study First Submitted QC: 2016-01-07
• Study First Posted: 2016-01-08
• Study Start: 2016-02
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-28
• Last Update Posted: 2016-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 122

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence A	Pegfilgrastim	3 doses of CHS-1701 or Neulasta, random order
Sequence C	Pegfilgrastim	3 doses of CHS-1701 or Neulasta, random order
Sequence A	CHS-1701	3 doses of CHS-1701 or Neulasta, random order
Sequence C	CHS-1701	3 doses of CHS-1701 or Neulasta, random order
Sequence B	CHS-1701	3 doses of CHS-1701 or Neulasta, random order
Sequence B	Pegfilgrastim	3 doses of CHS-1701 or Neulasta, random order

Primary Outcome Measures

Name	Time	Method
Bioequivalence as measured by PK and PD	84 Days	The primary objective of this study is to assess the bioequivalence of CHS-1701 with Neulasta® based on the pharmacokinetics (PK) of pegfilgrastim and the pharmacodynamic (PD) response as measured by absolute neutrophil count (ANC)

Secondary Outcome Measures

Name	Time	Method
PK Profile: t1/2	84 Days	Characterization of the PK profile of CHS-1701 using standard parameters of terminal elimination half-life (t1/2)
PK Profile: Cmax	84 Days	Characterization of the PK profile of CHS-1701 using standard parameters of maximum plasma concentration (Cmax)
PK Profile: AUC0-t	84 Days	Characterization of the PK profile of CHS-1701 using standard parameters of area under the plasma concentration versus time curve calculated from 0 to the last measurable observation (AUC0-t)
PK Profile: tmax	84 Days	Characterization of the PK profile of CHS-1701 using standard parameters of time to maximum plasma concentration (tmax)
Safety Profile as assessed by clinical adverse events (AEs), laboratory variables, vital signs, incidence of antidrug antibodies (ADAs), and local injection site reactions (ISRs)	84 Days	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).

Trial Locations

Locations (4)

Medpace CPU; 🇺🇸 Cincinnati, Ohio, United States

WCCT; 🇺🇸 Cypress, California, United States

Spaulding; 🇺🇸 West Bend, Wisconsin, United States

ICON; 🇺🇸 San Antonio, Texas, United States