Biosimilarity Study of Subcutaneous Pegfilgrastim in Healthy Volunteers

  • STATUS
    Recruiting
  • days left to enroll
    82
  • participants needed
    72
  • sponsor
    Megalabs
Updated on 30 April 2022
Accepts healthy volunteers

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.

Details
Condition Neutropenia
Treatment Pegfilgastrim Megalabs, Pegfilgastim Amgen
Clinical Study IdentifierNCT04873765
SponsorMegalabs
Last Modified on30 April 2022

Eligibility

Yes No Not Sure

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
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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