Biosimilarity Study of Intravenous Recombinant Human Erythropoietin in Healthy Volunteers

NCT04954989 | Not Yet Recruiting Phase 1

• 1 other identifier: RUBI
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy

Keywords

reticulocytes

Outcome Measures

Primary Outcomes (4)

• Evaluation of AUC0-inf

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

  14 days

• Evaluation Cmax

  Maximum plasma concentration for rHuEpo

  14 days

• Evaluation of Emax

  maximum increase in reticulocyte count

  14 days

• Evaluation of ASEC0-t

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

  14 days

Secondary Outcomes (2)

• half life

  14 days

• Tmax

  14 days

Study Arms (2)

Test rHuEpo in a single subcutaneous application.

EXPERIMENTAL

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

Biological: Experimental Erythropoietin subcutaneous injection single dose of 4,000 IU; Biological: Active comparator Erythropoietin subcutaneous injection single dose of 4,000 IU

Reference rHuEpo in a single subcutaneous application.

ACTIVE COMPARATOR

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

Biological: Experimental Erythropoietin subcutaneous injection single dose of 4,000 IU; Biological: Active comparator Erythropoietin subcutaneous injection single dose of 4,000 IU

Interventions

Experimental Erythropoietin subcutaneous injection single dose of 4,000 IU 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

Reference rHuEpo in a single subcutaneous application.; Test rHuEpo in a single subcutaneous application.

Active comparator Erythropoietin subcutaneous injection single dose of 4,000 IU 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.; Test rHuEpo in a single subcutaneous application.

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Megalabs: lead

Study Sites (1)

Azidus Laboratories

Chennai, India

Location

Study Officials

• Satish Kumar, MD

  Azidus Principal Investigator

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marcos Giusti, MD

CONTACT

+598926838000; mgiusti@megalabs.global

Victoria Rodríguez, MD

CONTACT

vrodriguez@megalabs.global

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2021
• First Posted: July 8, 2021
• Study Start: October 6, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: August 21, 2024

Record last verified: 2024-08

Locations

IN (1)