Biosimilarity Study of Subcutaneous Pegfilgrastim in Healthy Volunteers

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

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.

Study Overview

• Status: Recruiting
• Conditions: Neutropenia
• Intervention / Treatment: Biological: Pegfilgastrim Megalabs; Biological: Pegfilgastim Amgen

• Study Type: Interventional
• Enrollment (Anticipated): 72
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Marcos Giusti, MD; Phone Number: 3100 +598926838000; Email: mgiusti@megalabs.global
• Study Contact Backup: Name: Victoria Rodríguez, MD; Phone Number: +598926838000; Email: vrodrigez@megalabs.global

Study Locations

• Brazil
  • Montevideo, Brazil, 11300
    • Recruiting
    • Marcos Giusti
    • Contact: Marcos Giusti, PhD; Phone Number: 3110 26836300; Email: mgiusti@megalabs.global

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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;

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Megalabs
• Investigators: Principal Investigator: José Pedrazzoli Junior, MD, Unidade Integrada de Farmacologia e Gastroenterologia

Study record dates

Study Major Dates

• Study Start (Actual): March 18, 2022
• Primary Completion (Anticipated): August 18, 2022
• Study Completion (Anticipated): September 18, 2022

Study Registration Dates

• First Submitted: April 25, 2021
• First Submitted That Met QC Criteria: April 30, 2021
• First Posted (Actual): May 5, 2021

Study Record Updates

• Last Update Posted (Actual): April 15, 2022
• Last Update Submitted That Met QC Criteria: April 8, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Agranulocytosis; Leukopenia; Leukocyte Disorders; Neutropenia
• Other Study ID Numbers: GIGA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No