Clinical trial NCT04954989: Biosimilarity Study of Intravenous Recombinant Human Erythropoietin in Healthy Volunteers
Official title: Phase I Open and Monocentric Clinical Trial With Pharmacokinetic and Pharmacodynamic Determination of Intravenous Recombinant Human Erythropoietin in Male Adults.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Healthy
Keywords: reticulocytes
Lead sponsor: Megalabs
Sponsor class: INDUSTRY
First posted: 2021-07-08
Enrollment: 52
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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;

Primary outcomes:
measure: Evaluation of AUC0-inf
timeFrame: 14 days
measure: Evaluation Cmax
timeFrame: 14 days
measure: Evaluation of Emax
timeFrame: 14 days
measure: Evaluation of ASEC0-t
timeFrame: 14 days
Secondary outcomes:
measure: half life
timeFrame: 14 days
measure: Tmax
timeFrame: 14 days
Other outcomes:
Locations:
city: Chennai
country: India
facility: Azidus Laboratories
Study officials:
affiliation: Azidus Principal Investigator
name: Satish Kumar, MD
role: PRINCIPAL_INVESTIGATOR
References: