Biosimilarity Study of Subcutaneous Recombinant Human Erythropoietin in Healthy Volunteers

Healthy Clinical Trial

Official title:

Phase I Open and Monocentric Clinical Trial With Pharmacokinetic and Pharmacodynamic Determination of Subcutaneous Recombinant Human Erythropoietin in Male Adults.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04954989
• Other study ID #: RUBI
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: January 2023
• Est. completion date: December 2023

Study information

• Verified date: April 2022
• Source: Megalabs
• Contact: Marcos Giusti, MD
• Phone: +598926838000
• Email: mgiusti[@]megalabs.global
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 52
• Est. completion date: December 2023
• Est. primary completion date: March 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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;

Related Conditions & MeSH terms

• Healthy

Intervention

Biological:
• Experimental Erythropoietin subcutaneous injection single dose of 4,000 IU
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 Eprex® subcutaneous injection single dose of 4,000 IU
Recombinant Human Erythropoietin: single dose of 4,000 IU (syringe filled with 0.4 mL with 4,000 IU) of Eprex® should be administered subcutaneously

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Megalabs

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of AUC0-t		14 days
Primary	Evaluation Cmax		14 days
Primary	Evaluation of Emax		14 days
Primary	Evaluation of ASEC0-t		14 days
Secondary	Compare profiles for T½ between the experimental drug and the comparator.		14 days
Secondary	Compare profiles for Tmax between the experimental drug and the comparator.		14 days