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A Comparative Study to Evaluate the Effect of HSP-130, US-approved Neulasta and EU-approved Neulasta in Healthy Participants

Last updated on March 22, 2018

FOR MORE INFORMATION
Study Location
CMAX (a Division of IDT Australia Limited)
Adelaide, South Australia, 5000 Australia
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Neutropenia
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.
Show details

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 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

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

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/?L), leukopenia (defined as total leukocytes (defined as ANC

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) 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

NCT02629289
Pfizer
Completed
A Comparative Study to Evaluate the Effect of HSP-130, US-approved Neulasta and EU-approved Neulasta in Healthy Participants

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A Comparative Study to Evaluate the Effect of HSP-130, US-approved Neulasta and EU-approved Neulasta in Healthy Participants
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
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.
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).
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Neutropenia
  • Drug: HSP-130
    Other Name: Pegylated filgrastim
  • Drug: US-approved Neulasta
    Other Name: Pegfilgrastim, Amgen
  • Drug: EU-approved Neulasta
    Other Name: Pegfilgrastim, Amgen
  • Treatment A
    HSP-130, 6 mg, single subcutaneous (SC) injection in the deltoid region
    Intervention: Drug: HSP-130
  • Treatment B
    US-approved Neulasta, 6 mg, single SC injection in the deltoid region
    Intervention: Drug: US-approved Neulasta
  • Treatment C
    EU-approved Neulasta, 6 mg, single SC injection in the deltoid region
    Intervention: Drug: EU-approved Neulasta
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
153
June 2016
June 2016   (Final data collection date for primary outcome measure)

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

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/?L), leukopenia (defined as total leukocytes <4000/?L), neutropenia (defined as ANC <1500/?L) or thrombocytopenia (defined as platelet count of <150/?L)
  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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Australia
 
 
NCT02629289
ZIN-130-1505
C1221001 ( Other Identifier: Alias Study Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Hospira, now a wholly owned subsidiary of Pfizer
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 2016

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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