Biosimilarity Study of Intravenous Recombinant Human Erythropoietin in Healthy Volunteers

Phase 1

Not yet recruiting

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

• Registration Number: NCT04954989
• Lead Sponsor: Megalabs

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.

Study Timeline

• Study First Submitted: 2021-06-06
• Study First Submitted QC: 2021-07-06
• Study First Posted: 2021-07-08
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-16
• Last Update Posted: 2024-08-21
• Study Start: 2024-10-06
• Primary Completion: 2024-12-01
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 52

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Test rHuEpo in a single subcutaneous application.	Experimental Erythropoietin subcutaneous injection single dose of 4,000 IU	Group T: Test rHuEepo shall be administered subcutaneosly to study participants
Test rHuEpo in a single subcutaneous application.	Active comparator Erythropoietin subcutaneous injection single dose of 4,000 IU	Group T: Test rHuEepo shall be administered subcutaneosly to study participants
Reference rHuEpo in a single subcutaneous application.	Experimental Erythropoietin subcutaneous injection single dose of 4,000 IU	Group T: Reference rHuEepo shall be administered subcutaneosly to study participants
Reference rHuEpo in a single subcutaneous application.	Active comparator Erythropoietin subcutaneous injection single dose of 4,000 IU	Group T: Reference rHuEepo shall be administered subcutaneosly to study participants

Primary Outcome Measures

Name	Time	Method
Evaluation Cmax	14 days	Maximum plasma concentration for rHuEpo
Evaluation of Emax	14 days	maximum increase in reticulocyte count
Evaluation of AUC0-inf	14 days	Area under curve Cp(t) rHuEpo from time zero to infinity
Evaluation of ASEC0-t	14 days	Area under curve reticulocyte count f(t) from time zero to day 14

Secondary Outcome Measures

Name	Time	Method
half life	14 days	Compare profiles for T½ between the experimental drug and the comparator.
Tmax	14 days	Compare profiles for Tmax between the experimental drug and the comparator.

Trial Locations

Locations (1)

Azidus Laboratories; 🇮🇳 Chennai, India