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

Last updated on March 14, 2019

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Study Location
SeaView Research, Inc
Miami, Florida, 33126 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Neutropenia (Low White Blood Cell Count)
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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1. Provides written informed consent, approved by an Independent Ethics Committee
(IEC)/Institutional Review Board (IRB) prior to any study related activities

2. Healthy male or female volunteers between 18 and 65 years of age (both inclusive)

3. Body mass index (BMI) between 19 and 30 kg/m2, inclusive, and body weight of not kg or > 100 kg

4. Non smoker (defined as a subject who has not smoked and has not used nicotine
containing products for at least 3 months prior to study drug administration and has a
negative urine screen for cotinine) at Screening

5. Female subjects of childbearing potential, and male subjects and their partners of
childbearing potential, agree to pregnancy prevention throughout the duration of the
study (through the Final Visit). Subjects and their partners must agree to use of an
effective method of contraception, to avoid impregnation of females throughout the
course of the study. Subjects using oral contraceptives must be on a stable regimen
for at least 3 months prior to Screening. While the best way to avoid pregnancy is to
abstain from sexual activity, adequate forms of contraception to be used include oral
contraception, depot contraception, intrauterine device (IUD), and barrier
contraceptive methods, such as condoms and barrier creams/contraceptive jellies, and
spermicidals. Subjects and their partners who can become pregnant must use
contraception while on study drug from admission to the Final Visit. Male subjects
must also refrain from donating sperm from admission to the Final Visit

6. Agrees to abstain from alcohol consumption throughout duration of the study and has a
negative urine for alcohol at Screening

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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1. Any active systemic or immunologic disease or condition, including but not limited to
the following general categories: cardiovascular/pulmonary, hepatorenal, or systemic
infection, or lactation

2. Hematologic laboratory abnormalities including leukocytosis (defined as total
leukocytes > 11,000/µL), leukopenia (defined as total leukocytes neutropenia (defined as absolute neutrophil count [ANC] (defined as platelet count of

3. Clinically significant, as judged by the Investigator, vital sign, chest X-ray, or
12-lead ECG abnormality

4. History of biological growth factor exposure, including but not limited to filgrastim
and other G-CSFs in the context of treatment, prophylaxis, peripheral blood stem cell
mobilization, or previous investigational study setting

5. Drug sensitivity, allergic reaction to, or known hypersensitivity/idiosyncratic
reaction to Escherichia coli-derived proteins, filgrastim, pegfilgrastim, other
granulocyte colony-stimulating factors or any component of the product. Subjects with
the rare heredity problem of fructose intolerance are excluded due to the excipient
sorbitol

6. History of splenic rupture (or subject who is asplenic), pulmonary infiltrate or
pneumonia, sickle cell disease, chronic neutropenia, thrombocytopenia, or vasculitis

NCT02766647
Pfizer
Completed
A Research Study To Test How Filgrastim Hospira Works In The Body Of Healthy Study Subjects When Given By Subcutaneous Injection (Shot) Compared To An Already U.S.-Approved Drug Neupogen® (Amgen)

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[email protected]

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