Biosimilarity Study of Subcutaneous Pegfilgrastim in Healthy Volunteers (NCT04873765) | Clinical Trial Compass
CompletedPhase 1
Biosimilarity Study of Subcutaneous Pegfilgrastim in Healthy Volunteers
Uruguay72 participantsStarted 2022-03-18
Plain-language summary
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.
Who can participate
Age range18 Years – 55 Years
SexMALE
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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 …
What they're measuring
1
Evaluation of Cmax in healthy volunteers for test and reference
Timeframe: 16 days
2
Evaluation of AUC 0-t of pegfilgrastim in healthy volunteers for test and reference
Timeframe: 16 days
3
Evaluation of absolute neutrophil count (ANC) in healthy volunteers for test and reference