Health TrialsbyHealthPanel

Biosimilarity Study of Subcutaneous Filgrastim in Healthy Volunteers

ConditionHealthy
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age18-55
SponsorMegalabs

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • Filgrastim Megalabs

    Biological/Vaccine

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

  • Granulokine

    Biological/Vaccine

    Granulokine 5 μg/Kg/day, subcutaneous single dose

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Filgrastim MegalabsExperimental treatment 2 interventions
Group B: GranulokineActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Evaluation of AUC 0-t in healthy volunteers for test and reference.

Time frame
17 days
2

Evaluation of Cmax in healthy volunteers for test and reference.

Time frame
17 days
3

Evaluation of absolute neutrophil count (ANC) in healthy volunteers for test and reference.

Time frame
17 days

Secondary outcomes

1

Evaluation of CD34+ count for test and reference

Time frame
17 days

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Megalabs

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: