Biosimilarity Study of Intravenous Recombinant Human Erythropoietin in Healthy Volunteers (RUBI)

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy
• Intervention / Treatment: Biological: Experimental Erythropoietin subcutaneous injection single dose of 4,000 IU; Biological: Active comparator Erythropoietin subcutaneous injection single dose of 4,000 IU

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.

• Study Type: Interventional
• Enrollment (Estimated): 52
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Marcos Giusti, MD; Phone Number: +598926838000; Email: mgiusti@megalabs.global
• Study Contact Backup: Name: Victoria Rodríguez, MD; Email: vrodriguez@megalabs.global

Study Locations

• India
  • Chennai, India
    • Azidus Laboratories

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test rHuEpo in a single subcutaneous application.; Group T: Test rHuEepo shall be administered subcutaneosly to study participants	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; 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
Active Comparator: Reference rHuEpo in a single subcutaneous application.; Group T: Reference rHuEepo shall be administered subcutaneosly to study participants	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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
half life	Compare profiles for T½ between the experimental drug and the comparator.	14 days
Tmax	Compare profiles for Tmax between the experimental drug and the comparator.	14 days

Collaborators and Investigators

• Sponsor: Megalabs
• Investigators: Principal Investigator: Satish Kumar, MD, Azidus Principal Investigator

Study record dates

Study Major Dates

• Study Start (Estimated): October 6, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: June 6, 2021
• First Submitted That Met QC Criteria: July 6, 2021
• First Posted (Actual): July 8, 2021

Study Record Updates

• Last Update Posted (Actual): August 21, 2024
• Last Update Submitted That Met QC Criteria: August 16, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: reticulocytes
• Additional Relevant MeSH Terms: Hematinics; Epoetin Alfa
• Other Study ID Numbers: RUBI

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No