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Comparative Immunogenicity Study Comparing TPI-120 to Neulasta® in Healthy Adult Subjects

NCT03202927 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2018-07-05

No results posted yet for this study

Summary

This study will compare treatment emergent incidence rate of ADA between TPI-120 and US licensed Neulasta in normal healthy adult subjects

Conditions

  • Healthy Volunteers

Interventions

DRUG

PEGFILGRASTIM

Pegfilgrastim is a covalent conjugate of recombinant methionyl human granulocyte colony-stimulating factor and monomethoxy polyethylene glycol.

Sponsors & Collaborators

  • Celerion

    collaborator INDUSTRY

  • Adello Biologics, LLC

    lead INDUSTRY

Principal Investigators

  • Cindy Cui, MD · Adello Biologics, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-03-25
Primary Completion
2018-03-01
Completion
2018-04-12
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT03202927 on ClinicalTrials.gov