A Comparative Study to Evaluate the Effect of HSP-130, US-approved Neulasta and EU-approved Neulasta in Healthy Participants
NCT02629289
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
1. Provides written informed consent approved by an Independent Ethics Committee (IEC) 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/m^2, inclusive, and body weight of not <50 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 Follow-up 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. Adequate forms of contraception to be used include hormonal contraceptives (oral, patch, depot), intrauterine devices (IUD), barrier contraceptive methods, such as diaphragm, cervical cap/shield, male condoms and female condoms.Sexually active subjects must use contraception while on study drug from admission to the Follow-up Visit. Male subjects must also refrain from donating sperm from admission to the Follow-up visit 6. Willing and able to comply with the requirements of the protocol and available for the planned duration of the study
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. History of, or current, malignancy with the exception of adequately treated squamous
or basal cell carcinoma of the skin or cervical carcinoma in situ within 5 years
3. Any disease or condition that might interfere with the absorption, distribution,
metabolism, or excretion of the study drug or would place the subject at increased
risk
4. Hematologic laboratory abnormalities including leukocytosis (defined as total
leukocytes >11,000/μL), leukopenia (defined as total leukocytes <4000/μL), neutropenia
(defined as ANC <1500/μL) or thrombocytopenia (defined as platelet count of <150/μL)
5. Clinically significant, as judged by the investigator, vital sign or 12-lead ECG
abnormality
6. History of biological growth factor exposure, including but not limited to filgrastim
and other granulocyte-colony stimulating factors in the context of treatment,
prophylaxis, peripheral blood stem cell mobilization, or previous investigational
study setting. This also includes exclusion for history of interferon, epoetin, and
intravenous immunoglobulin (IVIG) exposure
7. Receipt of live vaccination, or exposure to communicable viral diseases such as,
varicella, mumps, or measles within the 4 weeks prior to Screening
8. Surgery within the 4 months prior to Screening
9. Use of any prescription medicine (with the exception of contraceptives) within 7 days
or at least 5 half-lives, whichever is longer. Use of oral or parenteral anticoagulant
or antiplatelet agents and corticosteroids should be specifically queried
10. Administration of a drug by depot injection (with exception of depot contraception)
within 30 days prior to Randomization or 5 half-lives of that drug, whichever is
longer
11. Use of over the counter medications, including aspirin and non-steroidal
anti-inflammatory drugs, or natural preparations (dietary supplement or herbal
product) within 7 days or at least 5 half-lives, whichever is longer. Vitamins and
calcium are allowed (not to exceed 100% Daily Value)
12. History of drug or alcohol abuse within 2 years prior to Randomization, as determined
by the investigator or a positive urine screen for drugs of abuse (UDS) at Screening.
Screening for drugs of abuse will minimally include cannabinoids, opiates,
barbiturates, amphetamines, cocaine, benzodiazepines, and alcohol
13. Drug sensitivity, allergic reaction to, or known hypersensitivity/idiosyncratic
reaction to Escherichia coli-derived proteins, filgrastim, other granulocyte-colony
stimulating factors, or pegylated agents
14. History of splenic rupture (or subject who is asplenic), pulmonary infiltrate or
pneumonia, sickle cell disease, chronic neutropenia, thrombocytopenia, or vasculitis
15. Any clinically significant, as determined by the investigator, abnormal laboratory
evaluations, including human immunodeficiency virus antibody (HIVAb), hepatitis B
virus surface antigen (HBsAg), hepatitis C virus antibody (HCVAb), and liver function
including alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 1.5
the upper limit of normal taken at Screening. Negative HIVAb status will be confirmed
at Screening and the results will be maintained confidentially by the study site
16. Donated or lost 475 mL or more blood volume (including plasmapheresis) or had a
transfusion of any blood product within 3 months prior to Screening
17. Participated in another clinical research study with administration of investigational
drug within 30 days prior to Randomization
18. Potentially not be able to comply with the requirements of this clinical trial, to
communicate effectively with study personnel, or is considered by the Investigator,
for any reason, to be an unsuitable candidate for the study
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Descriptive Information | ||||
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Brief Title ICMJE | A Comparative Study to Evaluate the Effect of HSP-130, US-approved Neulasta and EU-approved Neulasta in Healthy Participants | |||
Official Title ICMJE | A Phase 1 Study Assessing The Pharmacodynamic And Pharmacokinetic Equivalence Of HSP-130 With US-approved Neulasta (Registered) And EU-approved Neulasta (Registered) Administered As A Single Subcutaneous Dose To Healthy Volunteers | |||
Brief Summary | This study is for healthy participants. This study tests single dose of the research drug HSP-130 against two existing approved drugs United States - approved Neulasta and European Union-approved Neulasta. | |||
Detailed Description | There will be 25 healthy participants in each of the six sequence groups. A total of 150 participants will be studied in one site in Australia. In addition to the 150 participants included, alternate subjects will be asked to come to the site on the day prior to when dosing is scheduled to begin. There will be 3 treatment options with 3 study dosing periods (1, 2 and 3) and at least 56 days between each treatment. The subject once asked to take part in the study will be assigned by chance (randomized) to one of the sequence groups as mentioned above (1, 2, 3, 4, 5, or 6). | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: None (Open Label) | |||
Condition ICMJE | Neutropenia | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Moosavi S, Borema T, Ewesuedo R, Harris S, Levy J, May TB, Summers M, Thomas JS, Zhang J, Yao HM. PF-06881894, a Proposed Biosimilar to Pegfilgrastim, Versus US-Licensed and EU-Approved Pegfilgrastim Reference Products (Neulasta(®)): Pharmacodynamics, Pharmacokinetics, Immunogenicity, and Safety of Single or Multiple Subcutaneous Doses in Healthy Volunteers. Adv Ther. 2020 Jul;37(7):3370-3391. doi: 10.1007/s12325-020-01387-x. Epub 2020 Jun 10. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 153 | |||
Original Estimated Enrollment ICMJE | 150 | |||
Actual Study Completion Date ICMJE | June 2016 | |||
Actual Primary Completion Date | June 2016 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Subjects using oral contraceptives must be on a stable regimen for at least 3 months prior to Screening. Adequate forms of contraception to be used include hormonal contraceptives (oral, patch, depot), intrauterine devices (IUD), barrier contraceptive methods, such as diaphragm, cervical cap/shield, male condoms and female condoms.Sexually active subjects must use contraception while on study drug from admission to the Follow-up Visit. Male subjects must also refrain from donating sperm from admission to the Follow-up visit 6. Willing and able to comply with the requirements of the protocol and available for the planned duration of the study Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Australia | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT02629289 | |||
Other Study ID Numbers ICMJE | ZIN-130-1505 C1221001 ( Other Identifier: Alias Study Number ) | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Hospira, now a wholly owned subsidiary of Pfizer | |||
Investigators ICMJE |
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PRS Account | Pfizer | |||
Verification Date | July 2016 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |