NCT02766634

A Research Study To Test How Multiple Doses Of Filgrastim Hospira Works In The Body Of Healthy Study Subjects When Given by Subcutaneous Injection (SC) (Shot) Compared To An Already U.S.-Approved Drug Neupogen® (Amgen)

A Randomized Open-label, Multiple-dose, Crossover Study Evaluatig The Pharmacodynamics And Pharmacokinetics Of Filgrastim Hospira Compared To Us-approved Neupogen (Registered) Following Subcutaneous Administration To Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This is a study comparing two study drugs, Filgrastim Hospira and Neupogen®. Neupogen® is approved by the US Food and Drug Administration (FDA) to treat low numbers of specific kinds of white blood cells (WBC) known as neutrophils. This type of white cell is important in fighting infections. A low neutrophil count is known as neutropenia. Both drugs work by increasing the number of neutrophils that are produced in the body. This is important for patients who have low neutrophils due to chemotherapy, other treatments such as bone marrow transplant or certain other conditions with symptoms/problems related to low neutrophil counts. The main aim of the study is to test how Filgrastim Hospira works in the body compared to Neupogen®.

Detailed description

This is a randomized, open-label, multiple-dose, crossover study evaluating the pharmacodynamics and Pharmacokinetics equivalence following SC administration of test and reference product in healthy volunteers. The study will be conducted at a single Phase 1 unit. There will be 30 healthy subjects in each of the two sequences. After meeting the selection criteria, subjects will be randomly assigned to 1 of the 2 treatment sequences: * Filgrastim Hospira (US) in Period 1 followed by US-approved Neupogen® in Period 2. * US-approved Neupogen® in Period 1 followed by Filgrastim Hospira (US) in Period 2. Subjects will receive one of each of the drugs once a day for 5 days in each of the treatment sequences.

Conditions

• Neutropenia (Low White Blood Cell Count)

Interventions

Type	Name	Description
BIOLOGICAL	Filgrastim Hospira (US)	5 micrograms/kilogram (ug/kg) subcutaneous (SC) injection once a day for 5 days
BIOLOGICAL	U.S.-approved Neupogen®	5 micrograms/kilogram (ug/kg) subcutaneous (SC) injection once a day for 5 days

Timeline

• Start date: 2016-03-01
• Primary completion: 2016-06-01
• Completion: 2016-06-01
• First posted: 2016-05-10
• Last updated: 2016-07-21

Locations

2 sites across 1 country: United States