Biosimilarity Study of Intravenous Recombinant Human Erythropoietin in Healthy Volunteers

Launched by MEGALABS · Jul 6, 2021

Keywords

ClinConnect Summary

This clinical trial is looking at a medication called recombinant human erythropoietin, which is used to help boost the production of red blood cells. The goal is to understand how this medication works in healthy adult men when given through a specific injection method under the skin. The study is currently not recruiting participants, but when it does, it will involve males aged 18 to 55 who are in good health and meet certain medical criteria.

To participate, volunteers will need to be free from any major health issues, have a body weight between 60-100 kg, and pass a coronavirus test. They should not have any recent flu-like symptoms or significant health conditions that could affect their participation. Participants will receive the medication and will be monitored closely during the trial to see how their bodies respond to it. It's important for potential participants to understand that this is an early-phase study, which means it’s one of the first steps in testing this medication's effects.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • 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;
• • Have a body weight of 60 - 100 kg;
• • Present a 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, 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 );
• * Any clinical condition or laboratory alteration that, at the investigator's discretion, may compromise trial participation, ie:
• • Have an abnormal erythrocyte count (\<4.0 M/mm3 or \>5.4 M/mm3);
• • Have an abnormal reticulocyte count (\> 3.0%);
• • Have an abnormal platelet count (\< 135,000/μL or \> 550,000/μL);
• • Have an abnormal hemoglobin level (\< 13g/dL);
• • Have an abnormal level of hematocrit (\<40% or \>54%);
• • Have an abnormal level of ferritin (\< 100 ng/mL or \> 336.2 ng/mL);
• • Have an abnormal level of transferrin (\< 200 mg/dL or \> 360 mg/dL);
• • Have an abnormal level of transferrin saturation (\<20%)
• • Have abnormal levels of vitamin B12 (\< 130 pg/mL or \>868 pg/mL);
• • Present evidence of cardiovascular disorders, particularly arterial hypertension (supine blood pressure \> 145 / 90mmHg at baseline);
• • History of venous thrombosis;
• • Participants diagnosed with iron deficiency anemia or clinical history of autoimmune or hereditary anemia;
• • Clinical history of chronic or acute hemorrhages in the 30 days preceding the start of the trial;