Assessing the Immunogenicity of 2 Subcutaneous Doses of CHS-1701 (Coherus Pegfilgrastim) With 2 Subcutaneous Doses Neulasta®

Phase 1

Completed

• Conditions: Immunity, Humoral
• Interventions: Drug: Pegfilgrastim (Neulasta); Drug: CHS-1701

• Registration Number: NCT02418104
• Lead Sponsor: Coherus Biosciences, Inc.

Brief Summary

This is a randomized, double-blind, 2-period parallel study in healthy subjects to assess immunogenicity and safety of two sequential 6 mg subcutaneous (SC) injections of CHS-1701 compared with two sequential 6 mg SC injections of Neulasta®.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-04-08
• Study First Submitted QC: 2015-04-13
• Study First Posted: 2015-04-16
• Study Start: 2015-05
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-05
• Last Update Posted: 2016-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 303

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Neulasta	Pegfilgrastim (Neulasta)	Neulasta followed by Neulasta
CHS-1701	CHS-1701	CHS-1701 followed by CHS-1701

Primary Outcome Measures

Name	Time	Method
To assess the immunogenicity of CHS-1701 compared to Neulasta	84 days	The primary objective of this study is to assess the immunogenicity of CHS-1701 compared to Neulasta based on the development of neutralizing antibodies (NAB) and the percent difference in ADA response

Secondary Outcome Measures

Name	Time	Method
Any potential impact of ADA or NAB on the pharmacokinetic (PK) profile of CHS-1701 using standard parameters (AUC, Cmax, ANCmax, or ANC (AUC0-t)	84 days
Any potential impact of ADA or NAB on pharmacodynamic (PD) response as measured by absolute neutrophil count (ANC)	84 days
Any potential impact of ADA or NAB on safety profile and tolerance of CHS-1701, as assessed by clinical adverse events (AEs), laboratory variables, vital signs, and local injection site reactions (ISRs)	84 days

Trial Locations

Locations (4)

Vince & Associates Clinical Research; 🇺🇸 Overland Park, Kansas, United States

ICON; 🇺🇸 San Antonio, Texas, United States

Spaulding Clinical; 🇺🇸 West Bend, Wisconsin, United States

Medpace; 🇺🇸 Cincinnati, Ohio, United States