Biosimilarity Study of Subcutaneous Pegfilgrastim in Healthy Volunteers

Study Overview
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Brief Summary
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This study will compare the pharmacokinetics and pharmacodynamics, after single subcutaneous application, in healthy men, between pegfilgrastim formulation, produced by Megalabs (test product) and Neulastim® (reference product) Amgen.

Official Title
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Phase I Clinical Trial With Pharmacokinetic and Pharmacodynamic Determination of Subcutaneous Pegfilgrastim in Healthy Subjects

Conditions
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Neutropenia

Intervention / Treatment
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* Biological: Pegfilgastrim Megalabs
* Biological: Pegfilgastim Amgen


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pegfilgrastim Megalabs<br>Pegfilgrastim injectable 6 mg in a single subcutaneous application. | Biological: Pegfilgastrim Megalabs<br>* Administration of 6 mg of Pegfilgrastim Megalabs subcutaneous single dose<br>Biological: Pegfilgastim Amgen<br>* Administration of 6 mg of Pegfilgrastim Amgen subcutaneous single dose<br>|
| Active Comparator: Pegfilgastrim Neulastim<br>Neulastim injectable 6 mg in a single subcutaneous application. | Biological: Pegfilgastrim Megalabs<br>* Administration of 6 mg of Pegfilgrastim Megalabs subcutaneous single dose<br>Biological: Pegfilgastim Amgen<br>* Administration of 6 mg of Pegfilgrastim Amgen subcutaneous single dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of Cmax in healthy volunteers for test and reference |  | 16 days | 
| Evaluation of AUC 0-t of pegfilgrastim in healthy volunteers for test and reference |  | 16 days | 
| Evaluation of absolute neutrophil count (ANC) in healthy volunteers for test and reference |  | 16 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of CD34+ count for test and reference |  | 6 days |