- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04954989
Biosimilarity Study of Subcutaneous Recombinant Human Erythropoietin in Healthy Volunteers
April 8, 2022 updated by: Megalabs
Phase I Open and Monocentric Clinical Trial With Pharmacokinetic and Pharmacodynamic Determination of Subcutaneous Recombinant Human Erythropoietin in Male Adults.
Open label and monocentriC Phase I Clinical Trial, c 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
Study Type
Interventional
Enrollment (Anticipated)
52
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Marcos Giusti, MD
- Phone Number: +598926838000
- Email: mgiusti@megalabs.global
Study Contact Backup
- Name: Victoria Rodríguez, MD
- Email: vrodriguez@megalabs.global
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Erythropoietin injectable in a single subcutaneous application.
|
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
Recombinant Human Erythropoietin: single dose of 4,000 IU (syringe filled with 0.4 mL with 4,000 IU) of Eprex® should be administered subcutaneously
|
Active Comparator: Erythropoietin Eprex®
|
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
Recombinant Human Erythropoietin: single dose of 4,000 IU (syringe filled with 0.4 mL with 4,000 IU) of Eprex® should be administered subcutaneously
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Evaluation of AUC0-t
Time Frame: 14 days
|
14 days
|
Evaluation Cmax
Time Frame: 14 days
|
14 days
|
Evaluation of Emax
Time Frame: 14 days
|
14 days
|
Evaluation of ASEC0-t
Time Frame: 14 days
|
14 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Compare profiles for T½ between the experimental drug and the comparator.
Time Frame: 14 days
|
14 days
|
Compare profiles for Tmax between the experimental drug and the comparator.
Time Frame: 14 days
|
14 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: José Pedrazzoli Junior, MD, Unidade Integrada de Farmacologia e Gastroenterologia
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
January 1, 2023
Primary Completion (Anticipated)
March 1, 2023
Study Completion (Anticipated)
December 1, 2023
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)
April 12, 2022
Last Update Submitted That Met QC Criteria
April 8, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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