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Biosimilarity Study of Subcutaneous Pegfilgrastim in Healthy Volunteers

Sponsor
Megalabs (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04873765
Collaborator
(none)
72
Enrollment
1
Location
2
Arms
6
Anticipated Duration (Months)
11.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: Pegfilgastrim Megalabs
  • Biological: Pegfilgastim Amgen
 Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
72 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase I Clinical Trial With Pharmacokinetic and Pharmacodynamic Determination of Subcutaneous Pegfilgrastim in Healthy Subjects
Actual Study Start Date :
Mar 18, 2022
Anticipated Primary Completion Date :
Aug 18, 2022
Anticipated Study Completion Date :
Sep 18, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Evaluation of Cmax in healthy volunteers for test and reference [16 days]

  2. Evaluation of AUC 0-t of pegfilgrastim in healthy volunteers for test and reference [16 days]

  3. Evaluation of absolute neutrophil count (ANC) in healthy volunteers for test and reference [16 days]

Secondary Outcome Measures

  1. Evaluation of CD34+ count for test and reference [6 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

Site City State Country Postal Code
1 Marcos Giusti Montevideo Brazil 11300

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:
NCT04873765
Other Study ID Numbers:
  • GIGA
First Posted:
May 5, 2021
Last Update Posted:
Apr 15, 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:
Neutropenia

Study Results

No Results Posted as of Apr 15, 2022