Biosimilarity Study of Intravenous Recombinant Human Erythropoietin in Healthy Volunteers

NCT ID: NCT04954989

Last Updated: 2024-08-21

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-06
• Study Completion Date: 2024-12-31

Brief Summary

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

Detailed Description

An open label, balanced, randomized, two treatments, two sequences, two periods, single dose, crossover design will be used to study the pharmacokinetics and pharmacodynamics of two different rHuEpo products when administered subcutaneously in healthy subjects.

PK parameters to evaluate shall be AUCt and AUCt to infinity, and Cmax PD parameter shall be erithrocye and reticulocyte counts and hematocrite. Bioequivalence shall be evaluated according to 80-125 T/R rate for 90 % Cmax and AUC for pk and PD parameters.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Test rHuEpo in a single subcutaneous application.

Group T: Test rHuEepo shall be administered subcutaneosly to study participants

Group Type: EXPERIMENTAL

Experimental Erythropoietin subcutaneous injection single dose of 4,000 IU

Intervention Type: BIOLOGICAL

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

Intervention Type: BIOLOGICAL

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

Reference rHuEpo in a single subcutaneous application.

Group T: Reference rHuEepo shall be administered subcutaneosly to study participants

Group Type: ACTIVE_COMPARATOR

Experimental Erythropoietin subcutaneous injection single dose of 4,000 IU

Intervention Type: BIOLOGICAL

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

Intervention Type: BIOLOGICAL

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

Interventions

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

Intervention Type: BIOLOGICAL

Active comparator 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) should be administered subcutaneously

Intervention Type: BIOLOGICAL

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Megalabs

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Satish Kumar, MD

Role: PRINCIPAL_INVESTIGATOR

Azidus Principal Investigator

Locations

Azidus Laboratories

Chennai, , India

Countries

India

Central Contacts

Marcos Giusti, MD

Role: CONTACT

mgiusti@megalabs.global

+598926838000

Victoria Rodríguez, MD

Role: CONTACT

vrodriguez@megalabs.global

Other Identifiers

RUBI

Identifier Type: -

Identifier Source: org_study_id