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

NCT02418104 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 303

Last updated 2016-01-07

No results posted yet for this study

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®.

Conditions

  • Immunity, Humoral

Interventions

DRUG

CHS-1701

DRUG

Pegfilgrastim (Neulasta)

Sponsors & Collaborators

  • Coherus Oncology, Inc.

    lead INDUSTRY

Principal Investigators

  • Barbara Finck, MD · Coherus Oncology, Inc.

Study Design

Allocation
RANDOMIZED
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02418104 on ClinicalTrials.gov