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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02629289




Registration number
NCT02629289
Ethics application status
Date submitted
10/12/2015
Date registered
14/12/2015
Date last updated
15/07/2016

Titles & IDs
Public title
A Comparative Study to Evaluate the Effect of HSP-130, US-approved Neulasta and EU-approved Neulasta in Healthy Participants
Scientific title
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
Secondary ID [1] 0 0
C1221001
Secondary ID [2] 0 0
ZIN-130-1505
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neutropenia 0 0
Condition category
Condition code
Blood 0 0 0 0
Other blood disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other: Treatment A - HSP-130, 6 mg, single subcutaneous (SC) injection in the deltoid region

Other: Treatment B - US-approved Neulasta, 6 mg, single SC injection in the deltoid region

Other: Treatment C - EU-approved Neulasta, 6 mg, single SC injection in the deltoid region
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Area under the effect versus time curve for absolute neutrophil count (ANC) from the time of dose administration to 288 hours after dose administration (AUECANC)
Timepoint [1] 0 0
Within 1 hour prior to dose administration and at 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288 hours post-dose.
Primary outcome [2] 0 0
Maximum observed value for ANC (ANC_Cmax)
Timepoint [2] 0 0
Within 1 hour prior to dose administration and at 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288 hours post-dose.
Secondary outcome [1] 0 0
Time of maximum value for ANC (ANC_Tmax)
Timepoint [1] 0 0
Within 1 hour prior to dose administration and at 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288 hours post-dose.
Secondary outcome [2] 0 0
Area under the serum pegylated filgrastim versus time curve from the time of dose administration to time infinity (AUC0-8)
Timepoint [2] 0 0
Within 1 hour prior to dose and at 1, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288 hours post-dose.
Secondary outcome [3] 0 0
Maximum observed serum pegylated filgrastim concentration (Cmax)
Timepoint [3] 0 0
Within 1 hour prior to dose and at 1, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288 hours post-dose.
Secondary outcome [4] 0 0
Area under the serum pegylated filgrastim versus time curve from the time of dose administration to the time of last measurable concentration (AUC0-t)
Timepoint [4] 0 0
Within 1 hour prior to dose and at 1, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288 hours post-dose.
Secondary outcome [5] 0 0
Time to maximum serum pegylated filgrastim concentration (Tmax)
Timepoint [5] 0 0
Within 1 hour prior to dose and at 1, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288 hours post-dose.
Secondary outcome [6] 0 0
Elimination half-life (t1/2)
Timepoint [6] 0 0
Within 1 hour prior to dose and at 1, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288 hours post-dose.
Secondary outcome [7] 0 0
Elimination rate constant (?z)
Timepoint [7] 0 0
Within 1 hour prior to dose and at 1, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288 hours post-dose.

Eligibility
Key inclusion criteria
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
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
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

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2016
Sample size
Target
Accrual to date
Final
153
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
CMAX (a Division of IDT Australia Limited) - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Hospira, now a wholly owned subsidiary of Pfizer
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT02629289
Trial related presentations / 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(R)): 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.
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02629289