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Not yet recruiting NCT04958772

Biosimilarity Study of Subcutaneous Filgrastim in Healthy Volunteers

Phase I Interventional Healthy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Filgrastim Megalabs, Granulokine.
Who it may be relevant to
Registry conditions: Healthy. Basic parameters: 18 years — 55 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Clinical Trials Phase I, Single-Centric, Open, Randomized, Crossed, For Comparative Evaluation Of The Pharmacokinetic And Pharmacodynamic Profile Of The Filgrastim Injectable Solution, In Relation To The Comparison Granulokine®, Ltda. After Subcutaneous Multiple Administration In Healthy Participants

Overview

This study will compare the pharmacokinetics and pharmacodynamics, after single subcutaneous application, in healthy men, between filgrastim formulation, produced by Megalabs (test product) and Granulokine® (reference product) Amgen.

Interventions

  • Biological Filgrastim Megalabs
    Filgrastim Megalabs 5 μg/Kg/day, subcutaneous single dose
  • Biological Granulokine
    Granulokine 5 μg/Kg/day, subcutaneous single dose

Primary outcome measures

  • Evaluation of AUC 0-t in healthy volunteers for test and reference. [Time frame: 17 days]
  • Evaluation of Cmax in healthy volunteers for test and reference. [Time frame: 17 days]
  • Evaluation of absolute neutrophil count (ANC) in healthy volunteers for test and reference. [Time frame: 17 days]
Secondary outcome measures (1)
  • Evaluation of CD34+ count for test and reference [Time frame: 17 days]

Eligibility criteria

Inclusion criteria

  • Healthy eligible participants able to read, understand and sign the latest version of the Informed Consent Form (ICF) approved by the Research Ethics Committee (CEP)
  • Males aged between 18 and 55 years
  • Be characterized as a healthy research participant, based on medical history general physical examination and vital signs, laboratory tests and electrocardiogram (ECG),
  • Not indicating any evidence of disease
  • Body weight between 60-100 kg
  • Body Mass Index (BMI) ≥ 18.5 and ≤ 29.9 Kg / m2
  • Negative test for coronavirus

Exclusion criteria

  • Present one or more flu-like symptoms such as: fever (body temperature greater than or equal to 37.8 ° C), cough, dyspnoea, myalgia and fatigue, respiratory symptoms, gastrointestinal symptoms (such as diarrhea) within 7 days prior to the hospitalization period (all periods)
  • Direct and significant medical contact with people who tested positive for coronavirus testing within 14 days prior to the hospitalization period (all periods)
  • Living in the same household as people who are in the risk group with the worst prognosis for coronavirus infection, such as individuals over 60, individuals with respiratory problems, immunosuppressed or those with chronic diseases, such as heart or diabetes (all periods)
  • Participants diagnosed with malignant disease in the last 5 years, with the exception of successfully treated basal cell carcinoma
  • Participants with a previous diagnosis of severe asthma, sickle cell anemia, idiopathic urticaria or anaphylaxis
  • Participants with chronic diseases and, therefore, who regularly use medications
  • Being a smoker or quitting less than 6 months ago
  • Participants who consume more than 5 cups of tea or coffee a day and who cannot - abstain during the trial period
  • History of alcohol and illicit drug abuse
  • Electrocardiogram (ECG) findings that, at the investigator's discretion, may compromise participation in the trial
  • History or presence of gastrointestinal or liver diseases or any other condition that interferes with the absorption, distribution, excretion or metabolism of the drug
  • Use of lithium 2 weeks before and / or after medication administration
  • Participants who are hypersensitive or contraindicated to use any of the components of the formulation
  • Research participants who have participated in clinical trial protocols in the last 12 (twelve) months (Resolution CNS 251, of August 7, 1997, item III, subitem J)
  • Have donated blood (> 500 mL) or have undergone major surgery in the 3 (three) months preceding the date of signing the informed consent form
  • Have received any vaccine in the 3 (three) months preceding the date of signing the informed consent form

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT04958772 · LATIM

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗