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Study Comparing TPI-120 and Neulasta Administered Through Subcutaneous Route in Healthy Adult Subjects

NCT03206229 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2018-07-03

No results posted yet for this study

Summary

This is a single or up to 2 centers, double-blind, randomized, single-dose, two-way, crossover study comparing the Test (T) and Reference (R) products following subcutaneous administration. Subjects will be randomly assigned to one of two treatments sequences (TR or RT).

All subjects will be dosed at the CRO's designated clinical site(s) and the same protocol requirements and procedures will be followed within each group.

Conditions

  • Healthy Volunteers

Interventions

DRUG

PEG-rhG-CSF

PEG-rhG-CSF is going to be administered 2 mg/0.2 ml subcutaneously single dose in each study period as per the randomization schedule

DRUG

Neulasta (PEG-rhG-CSF)

PEG-rhG-CSF is going to be administered 2 mg/0.2 ml subcutaneously single dose in each study period as per the randomization schedule

Sponsors & Collaborators

  • inVentiv Health Clinical

    collaborator OTHER

  • Adello Biologics, LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2017-02-13
Primary Completion
2017-06-02
Completion
2018-01-18
FDA Drug
Yes

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 NCT03206229 on ClinicalTrials.gov