A Study in Healthy Volunteers to Assess Immune Response to Multiple Injections of Filgrastim Hospira or Neupogen Reference Product.

NCT02923791 | Completed Phase 1

• 3 other identifiers: C1121012FILGRASTIM IMMUNOGENICITY USCOMPARATIVE IMMUNOGENICITY
• Study Type: interventional
• Target: 256
• Locations: 1 country
• Sites: 3

Brief Summary

This study compares the potential immunogenicity of two filgrastims, the proposed biosimilar Filgrastim Hospira (US) and the US-approved Neupogen reference product. Subjects will receive doses of one of the two filgrastims by injection of 5 micrograms/kilogram (mcg/kg). Subjects will receive 5 consecutive daily doses in Period 1 (Days 1-5) and a single dose on Day 1 of Period 2. Pre-dose and serial post-dose assessments of immunogenicity will be conducted each of the two study periods. In addition, safety assessments will be conducted throughout the study.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• The proportion of subjects with a negative baseline anti-drug antibody (ADA) test result and confirmed post-dose positive ADA test result at any time during the study.

  62 days (Period 1 Day 0 through Period 2 Day 31 or Final Visit)

Secondary Outcomes (1)

• The proportion of subjects with a negative baseline ADA test result and post-dose positive neutralizing antibody result at any time during the study;

  62 days (Period 1 Day 0 through Period 2 Day 31 or Final Visit)

Study Arms (2)

Filgrastim Hospira

EXPERIMENTAL

Biological: Filgrastim Hospira

US-Approved Neupogen

ACTIVE COMPARATOR

Biological: US-Approved Neupogen

Interventions

Filgrastim Hospira BIOLOGICAL

5 consecutive daily doses (Days 1-5) in Period 1 and 1 dose (Day 1) in Period 2.

Also known as: Filgrastim

Filgrastim Hospira

US-Approved Neupogen BIOLOGICAL

5 consecutive daily doses (Days 1-5) in Period 1 and 1 dose (Day 1) in Period 2.

Also known as: Filgrastim

US-Approved Neupogen

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
• Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
• Healthy male or female volunteers between 18 and 65 years of age (both inclusive).
• Body mass index (BMI) between 19 and 30 kg/m2, inclusive, and body weight of not \< 50 kg or \>95 kg.
• Subjects have abstained from the use of tobacco- or nicotine-containing products for at least 90 days prior to dosing and have a negative urine screen for cotinine at Screening.
• Agrees to abstain from alcohol consumption for at least 48 hours prior to Day 1 of dosing in each study period and throughout the 5 days of study treatment and has a negative urine screen for alcohol at Screening.
• Female subjects of non-childbearing potential must meet at least 1 of the following criteria:
• Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; status will be confirmed by having a serum follicle-stimulating hormone (FSH) level confirming the postmenopausal state;
• Have undergone a documented hysterectomy and/or bilateral oophorectomy;
• Have medically confirmed ovarian failure. All other female subjects (including female subjects with tubal ligations) are considered to be of childbearing potential

You may not qualify if:

• Subjects with any of the following characteristics/conditions will not be included in the study:
• Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.
• Participation in other studies involving an investigational drug within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of investigational product (whichever is longer) prior to study entry and/or during study participation.
• Acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
• 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.
• History of malignancy 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.
• 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.
• 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 \[ANC\] \<1500/mcL), or thrombocytopenia (defined as platelet count of \<150/mcL).
• Lacks adequate hepatic reserve as defined by aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≥ 1.5 x the upper limit of normal (ULN) of the reference lab; lack of renal reserve as defined by serum creatinine of ≥1.2 x ULN for reference lab or estimated glomerular filtration rate (eGFR) of ≤ 80 mg/min; or has known history of glomerulonephritis.
• Clinically significant, as judged by the investigator, vital sign, or 12-lead electrocardiogram (ECG) abnormality.
• History of biological growth factor exposure, including but not limited to filgrastim and other G-CSFs in the context of treatment, prophylaxis, peripheral blood stem cell mobilization, or previous investigational study setting.
• Receipt of live vaccination, or exposure to communicable viral diseases such as chicken pox, varicella, or measles within the 4 weeks prior to Screening.
• Surgery within the 4 months prior to Screening.
• 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.
• Administration of a drug by depot injection (with exception of depot contraception) within 30 days prior to the initial study drug administration or 5 half-lives of that drug, whichever is longer.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (3)

SeaView Research, Inc.

Coral Gables, Florida, 33134, United States

Location

Seaview Jacksonville LLC

Jacksonville, Florida, 32256, United States

Location

SeaView Research, Inc.

Miami, Florida, 33126, United States

Location

Related Publications (1)

• Yao HM, Ottery FD, Borema T, Harris S, Levy J, May TB, Moosavi S, Zhang J, Summers M. PF-06881893 (Nivestym), a Filgrastim Biosimilar, Versus US-Licensed Filgrastim Reference Product (US-Neupogen(R)): Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Safety of Single or Multiple Subcutaneous Doses in Healthy Volunteers. BioDrugs. 2019 Apr;33(2):207-220. doi: 10.1007/s40259-019-00343-8.

  PMID: 30900158 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Interventions

Filgrastim

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2016
• First Posted: October 5, 2016
• Study Start: October 1, 2016
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: February 23, 2017

Record last verified: 2017-02

Locations

US (3)