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
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
Treatments tested in this trial
- Experimental Erythropoietin subcutaneous injection single dose of 4,000 IU
- Active comparator Erythropoietin subcutaneous injection single dose of 4,000 IU
Treatment groups
52 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov