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COMPLETEDPHASE1

Biosimilarity Study of Subcutaneous Pegfilgrastim in Healthy Volunteers

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

NCT04873765•Megalabs

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 55 years

Sex

MALE

Healthy Volunteers

Yes

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;
+6 more criteria

Locations (1)

Marcos Giusti

Montevideo, Uruguay

Key Dates

Start Date

March 18, 2022

Primary Completion Date

August 18, 2022

Completion Date

September 18, 2022

Last Updated

August 16, 2024

Enrollment

ACTUAL participants

Conditions

Neutropenia

Interventions

Pegfilgastrim Megalabs

BIOLOGICAL

Pegfilgastim Amgen

BIOLOGICAL

A Study of Mavorixafor in Participants With Congenital and Acquired Primary Autoimmune and Idiopathic Chronic Neutropenic Disorders Who Are Experiencing Recurrent and/or Serious Infections

NCT06056297

Neutropenia

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RECRUITING

Shwachman-Diamond Syndrome Global Patient Survey and Partnering Platform

NCT06999954

Shwachman-Diamond SyndromeSDS+25 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 16, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Biosimilarity Study of Subcutaneous Pegfilgrastim in Healthy Volunteers

Inclusion Criteria

Exclusion Criteria

A Study of Mavorixafor in Participants With Congenital and Acquired Primary Autoimmune and Idiopathic Chronic Neutropenic Disorders Who Are Experiencing Recurrent and/or Serious Infections

Shwachman-Diamond Syndrome Global Patient Survey and Partnering Platform

Luspatercept for Clonal Cytopenias of Uncertain Significance

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