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

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NCT03273842

Last updated on October 10, 2018
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FOR MORE INFORMATION
Study Location
Seaview A Quotient Clinical Business
Coral Gables, Florida, 33134 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
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 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 neutropenia [defined as absolute neutrophil count [defined as platelet count of 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.

NCT03273842
Pfizer
Completed
A Study to Assess Immune Response to Multiple Doses of PF-06881894 or US-Approved Neulasta in Healthy Volunteers

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Pfizer Clinical Trials Contact Center

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[email protected]

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A Study to Assess Immune Response to Multiple Doses of PF-06881894 or US-Approved Neulasta in Healthy Volunteers
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
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Healthy Volunteers
  • Biological: PF-06881894
    pre-filled syringe 6 mg
  • Biological: US-approved Neulasta
    pre-filled syringe 6 mg
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
420
June 25, 2018
June 25, 2018   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
Yes

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
United States
 
 
NCT03273842
C1221005
IMM HSP-130 ( Other Identifier: Alias Study Number )
Not Provided
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
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/da...
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2017

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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Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

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[email protected]



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