Biosimilarity Study of Subcutaneous Pegfilgrastim in Healthy Volunteers

Neutropenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04873765
• Other study ID #: GIGA
• Status: Recruiting
• Phase: Phase 1
• Start date: March 18, 2022
• Est. completion date: September 18, 2022

Study information

• Verified date: April 2022
• Source: Megalabs
• Contact: Marcos Giusti, MD
• Phone: +598926838000
• Email: mgiusti[@]megalabs.global
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: September 18, 2022
• Est. primary completion date: August 18, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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;

Related Conditions & MeSH terms

• Neutropenia

Intervention

Biological:
• Pegfilgastrim Megalabs
Administration of 6 mg of Pegfilgrastim Megalabs subcutaneous single dose
• Pegfilgastim Amgen
Administration of 6 mg of Pegfilgrastim Amgen subcutaneous single dose

Locations

Country	Name	City	State
Brazil	Marcos Giusti	Montevideo

Sponsors (1)

Lead Sponsor	Collaborator
Megalabs

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of Cmax in healthy volunteers for test and reference		16 days
Primary	Evaluation of AUC 0-t of pegfilgrastim in healthy volunteers for test and reference		16 days
Primary	Evaluation of absolute neutrophil count (ANC) in healthy volunteers for test and reference		16 days
Secondary	Evaluation of CD34+ count for test and reference		6 days