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Biosimilarity Study of Subcutaneous Filgrastim in Healthy Volunteers

Sponsor
Megalabs (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT04958772
Collaborator
(none)
100
Enrollment
2
Arms
12
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

This study will compare the pharmacokinetics and pharmacodynamics, after single subcutaneous application, in healthy men, between filgrastim formulation, produced by Megalabs (test product) and Granulokine® (reference product) Amgen.

Condition or Disease Intervention/Treatment Phase
  • Biological: Filgrastim Megalabs
  • Biological: Granulokine
 Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Clinical Trials Phase I, Single-Centric, Open, Randomized, Crossed, For Comparative Evaluation Of The Pharmacokinetic And Pharmacodynamic Profile Of The Filgrastim Injectable Solution, In Relation To The Comparison Granulokine®, Ltda. After Subcutaneous Multiple Administration In Healthy Participants
Anticipated Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Mar 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Filgrastim Megalabs

Filgrastim Megalabs injectable 5 μg/Kg/day in a single subcutaneous application during 5 days

Biological: Filgrastim Megalabs
Filgrastim Megalabs 5 μg/Kg/day, subcutaneous single dose

Biological: Granulokine
Granulokine 5 μg/Kg/day, subcutaneous single dose
Active Comparator: Granulokine

Granulokine injectable 5 μg/Kg/day in a single subcutaneous application during 5 days

Biological: Filgrastim Megalabs
Filgrastim Megalabs 5 μg/Kg/day, subcutaneous single dose

Biological: Granulokine
Granulokine 5 μg/Kg/day, subcutaneous single dose

Outcome Measures

Primary Outcome Measures

  1. Evaluation of AUC 0-t in healthy volunteers for test and reference. [17 days]

  2. Evaluation of Cmax in healthy volunteers for test and reference. [17 days]

  3. Evaluation of absolute neutrophil count (ANC) in healthy volunteers for test and reference. [17 days]

Secondary Outcome Measures

  1. Evaluation of CD34+ count for test and reference [17 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
Male
Accepts 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

  • 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Megalabs

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Megalabs
ClinicalTrials.gov Identifier:
NCT04958772
Other Study ID Numbers:
  • LATIM
First Posted:
Jul 12, 2021
Last Update Posted:
Apr 12, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Lenograstim

Study Results

No Results Posted as of Apr 12, 2022