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Biosimilarity Study of Intravenous Recombinant Human Erythropoietin in Healthy Volunteers

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

About this trial

Open label and monocentric Phase I Clinical Trial, to Determine the Pharmacokinetics and Pharmacodynamics of Recombinant Human Erythropoietin for Subcutaneous Use in an Adult Male Population

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 (FICF) approved by the Research Ethics Committee (CEP);

Male participants 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 ECG not indicating any evidence of disease;

Present BMI ≥ 18 and ≤ 29.9 Kg/m2;

Disqualifiers

Present one or more flu-like symptoms such as: fever (body temperature greater than or equal to 37.8°C), cough, dyspnea, myalgia and fatigue, respiratory symptoms, gastrointestinal symptoms (such as diarrhea) within 7 days prior to the hospital stay (all periods);

Having had direct and significant contact, at the medical discretion, with people who tested positive for a coronavirus test within 14 days prior to the hospital stay (all periods);

Living in the same household as people who fall into the risk group of worse prognosis for coronavirus infection, such as individuals over 60 years old, individuals with respiratory problems, immunosuppressed or those with chronic diseases such as heart or diabetes (all periods );

Have an abnormal erythrocyte count (<4.0 M/mm3 or >5.4 M/mm3);

Trial design

Design model

Crossover

Treatments tested in this trial

  • Experimental Erythropoietin subcutaneous injection single dose of 4,000 IU

    Biological/Vaccine

    Recombinant Human Erythropoietin: single dose of 4,000 IU (syringe filled with 0.4 mL with 4,000 IU) of the experimental drug should be administered subcutaneously

  • Active comparator Erythropoietin subcutaneous injection single dose of 4,000 IU

    Biological/Vaccine

    Recombinant Human Erythropoietin: single dose of 4,000 IU (syringe filled with 0.4 mL with 4,000 IU) should be administered subcutaneously

Treatment groups

52 Participants
are divided into 2 treatment groups
Group A: Test rHuEpo in a single subcutaneous application.Experimental treatment 2 interventions
Group B: Reference rHuEpo in a single subcutaneous application.Active comparator 2 interventions

Trial outcomes

Primary outcomes

1

Evaluation of AUC0-inf

Area under curve Cp(t) rHuEpo from time zero to infinity

Time frame
14 days
2

Evaluation Cmax

Maximum plasma concentration for rHuEpo

Time frame
14 days
3

Evaluation of Emax

maximum increase in reticulocyte count

Time frame
14 days
4

Evaluation of ASEC0-t

Area under curve reticulocyte count f(t) from time zero to day 14

Time frame
14 days

Secondary outcomes

1

half life

Compare profiles for T½ between the experimental drug and the comparator.

Time frame
14 days
2

Tmax

Compare profiles for Tmax between the experimental drug and the comparator.

Time frame
14 days

Other outcomes

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: