Biosimilarity Study of Subcutaneous Pegfilgrastim in Healthy Volunteers

NCT04873765 | Completed Phase 1

• 1 other identifier: GIGA
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neutropenia

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Evaluation of CD34+ count for test and reference

  6 days

Study Arms (2)

Pegfilgrastim Megalabs

EXPERIMENTAL

Pegfilgrastim injectable 6 mg in a single subcutaneous application.

Biological: Pegfilgastrim Megalabs; Biological: Pegfilgastim Amgen

Pegfilgastrim Neulastim

ACTIVE COMPARATOR

Neulastim injectable 6 mg in a single subcutaneous application.

Biological: Pegfilgastrim Megalabs; Biological: Pegfilgastim Amgen

Interventions

Pegfilgastrim Megalabs BIOLOGICAL

Administration of 6 mg of Pegfilgrastim Megalabs subcutaneous single dose

Pegfilgastrim Neulastim; Pegfilgrastim Megalabs

Pegfilgastim Amgen BIOLOGICAL

Administration of 6 mg of Pegfilgrastim Amgen subcutaneous single dose

Pegfilgastrim Neulastim; Pegfilgrastim Megalabs

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Megalabs: lead

Study Sites (1)

Marcos Giusti

Montevideo, 11300, Uruguay

Location

MeSH Terms

Conditions

Neutropenia

Condition Hierarchy (Ancestors)

Agranulocytosis; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders

Study Officials

• José Pedrazzoli Junior, MD

  Unidade Integrada de Farmacologia e Gastroenterologia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2021
• First Posted: May 5, 2021
• Study Start: March 18, 2022
• Primary Completion: August 18, 2022
• Study Completion: September 18, 2022
• Last Updated: August 16, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

UR (1)