A Study to Assess Immune Response to Multiple Doses of PF-06881894 or US-Approved Neulasta in Healthy Volunteers

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NCT03273842

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Study Location
Seaview A Quotient Clinical Business
Coral Gables, Florida, 33134, United States
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Contact
1-800-718-1021
[email protected]
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FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy Volunteers
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

• Healthy males or females between 18 and 65 years of age (both inclusive) with body mass index between 19 and 30 kg/m2, inclusive, and body weight of not <50 kg or >95 kg, will be enrolled in this study.

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


- Hematologic laboratory abnormalities (including leukocytosis [defined as total
leukocytes >11,000/mcL], leukopenia [defined as total leukocytes <4000/mcL], or
neutropenia [defined as absolute neutrophil count <1500/mcL] or thrombocytopenia
[defined as platelet count of <150,000/mcL]) or other clinically significant abnormal
laboratory evaluations.


- Lack of adequate hepatic or renal reserve.


- Any active systemic or immunologic disease or condition.


- History of biological growth factor exposure.


- Received live vaccination or exposure to communicable viral diseases within 4 weeks
prior to Screening.

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Study to Assess Immune Response to Multiple Doses of PF-06881894 or US-Approved Neulasta in Healthy Volunteers
Official Title  ICMJE Phase 1, Randomized Open Label, Multiple Dose, Parallel Study To Assess The Immunogenicity Of Multiple Subcutaneous (SC) Doses Of The Proposed Pegfilgrastim Biosimilar (PF-06881894) And Us-approved Neulasta (Registered) In Healthy Volunteers
Brief Summary This study compares the immune response to the proposed biosimilar PF-06881894 and the US-approved Neulasta reference product. Subjects will receive 2 subcutaneous injections (6 milligrams [mg]) either 1 of the 2 study drugs. Subjects will receive the first dose on Day 1 of Period 1 and the second dose on Day 1 of Period 2. Pre-dose and serial post-dose assessments of immunogenicity will be conducted each of the two treatment periods. In addition, safety assessments will be conducted throughout the study.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Healthy Volunteers
Intervention  ICMJE
  • Biological: PF-06881894
    pre-filled syringe 6 mg
  • Biological: US-approved Neulasta
    pre-filled syringe 6 mg
Study Arms  ICMJE
  • Experimental: PF-06881894
    PF-06881894 6 mg SC
    Intervention: Biological: PF-06881894
  • Active Comparator: US-approved Neulasta
    US-approved Neulasta 6 mg SC
    Intervention: Biological: US-approved Neulasta
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
 (submitted: August 15, 2018)		422
Original Estimated Enrollment  ICMJE
 (submitted: September 5, 2017)		420
Actual Study Completion Date  ICMJE July 25, 2018
Actual Primary Completion Date July 25, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

? Healthy males or females between 18 and 65 years of age (both inclusive) with body mass index between 19 and 30 kg/m2, inclusive, and body weight of not <50 kg or >95 kg, will be enrolled in this study.

Exclusion Criteria:

  • Hematologic laboratory abnormalities (including leukocytosis [defined as total leukocytes >11,000/mcL], leukopenia [defined as total leukocytes <4000/mcL], or neutropenia [defined as absolute neutrophil count <1500/mcL] or thrombocytopenia [defined as platelet count of <150,000/mcL]) or other clinically significant abnormal laboratory evaluations.
  • Lack of adequate hepatic or renal reserve.
  • Any active systemic or immunologic disease or condition.
  • History of biological growth factor exposure.
  • Received live vaccination or exposure to communicable viral diseases within 4 weeks prior to Screening.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03273842
Other Study ID Numbers  ICMJE C1221005
IMM HSP-130 ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Plan Description:Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/d…
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP