HealthyPhase 1RUBINCT04954989
Biosimilarity Study of Intravenous Recombinant Human Erythropoietin in Healthy Volunteers
A Phase 1 study testing Experimental Erythropoietin subcutaneous injection single dose of 4,000 IU and Active comparator Erythropoietin subcutaneous injection single dose of 4,000 IU in people with Healthy, run by Megalabs at 1 site in India.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Experimental Erythropoietin subcutaneous injection single dose of 4,000 IU and Active comparator Erythropoietin subcutaneous injection single dose of 4,000 IU
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteIndia
- Study dates
- 6 Oct 2024to Dec 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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%);
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- 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;
Trial locations and contacts
1 site in 1 country.
Victoria Rodríguez, MD contact
About this study
Official title: 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
Read the 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.
- Conditions
- Healthy
- Being tested
- Experimental Erythropoietin subcutaneous injection single dose of 4,000 IU, Active comparator Erythropoietin subcutaneous injection single dose of 4,000 IU
- Keywords
- reticulocytes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental Erythropoietin subcutaneous injection single dose of 4,000 IUBiological
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
Active comparator Erythropoietin subcutaneous injection single dose of 4,000 IUBiological
Recombinant Human Erythropoietin: single dose of 4,000 IU (syringe filled with 0.4 mL with 4,000 IU) should be administered subcutaneously
| Study group | Role | What they receive |
|---|---|---|
| Test rHuEpo in a single subcutaneous application. | Experimental | Group T: Test rHuEepo shall be administered subcutaneosly to study participants Receives: 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 Receives: Biological: Experimental Erythropoietin subcutaneous injection single dose of 4,000 IU; Biological: Active comparator Erythropoietin subcutaneous injection single dose of 4,000 IU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of AUC0-inf
Area under curve Cp(t) rHuEpo from time zero to infinity
Measured: 14 days
Evaluation Cmax
Maximum plasma concentration for rHuEpo
Measured: 14 days
Evaluation of Emax
maximum increase in reticulocyte count
Measured: 14 days
Evaluation of ASEC0-t
Area under curve reticulocyte count f(t) from time zero to day 14
Measured: 14 days
Secondary outcomes (2)
half life
Compare profiles for T½ between the experimental drug and the comparator.
Measured: 14 days
Tmax
Compare profiles for Tmax between the experimental drug and the comparator.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2021
- Study start6 Oct 2024 (estimated)
- Primary completion1 Dec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Megalabs
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Satish Kumar, MD, Principal investigator, Azidus Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04954989
- Sponsor's protocol ID
- RUBI
- Acronym
- RUBI
- Status last verified
- Aug 2024
- First submitted
- 6 Jun 2021
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Open and Monocentric Clinical Trial With Pharmacokinetic and Pharmacodynamic Determination of Intravenous Recombinant Human Erythropoietin in Male Adults.
- ClinicalTrials.gov ID
- NCT04954989
- Acronym / sponsor ID
- RUBI / RUBI
- Conditions
- Healthy
- Keywords
- reticulocytes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- MegalabsIndustry (pharma, biotech, devices)
- Study start
- 6 Oct 2024 (estimated)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 8 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test rHuEpo in a single subcutaneous application. | Experimental | Biological: Experimental Erythropoietin subcutaneous injection single dose of 4,000 IU, Biological: Active comparator Erythropoietin subcutaneous injection single dose of 4,000 IUGroup T: Test rHuEepo shall be administered subcutaneosly to study participants |
| Reference rHuEpo in a single subcutaneous application. | Active comparator | Biological: Experimental Erythropoietin subcutaneous injection single dose of 4,000 IU, Biological: Active comparator Erythropoietin subcutaneous injection single dose of 4,000 IUGroup T: Reference rHuEepo shall be administered subcutaneosly to study participants |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (17 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental Erythropoietin subcutaneous injection single dose of 4,000 IURecombinant 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 | Reference rHuEpo in a single subcutaneous application., Test rHuEpo in a single subcutaneous application. |
| Active comparator Erythropoietin subcutaneous injection single dose of 4,000 IURecombinant Human Erythropoietin: single dose of 4,000 IU (syringe filled with 0.4 mL with 4,000 IU) should be administered subcutaneously | Biological | Reference rHuEpo in a single subcutaneous application., Test rHuEpo in a single subcutaneous application. |
Primary outcome
Evaluation of AUC0-inf
Time frame: 14 days
Area under curve Cp(t) rHuEpo from time zero to infinity
Evaluation Cmax
Time frame: 14 days
Maximum plasma concentration for rHuEpo
Evaluation of Emax
Time frame: 14 days
maximum increase in reticulocyte count
Evaluation of ASEC0-t
Time frame: 14 days
Area under curve reticulocyte count f(t) from time zero to day 14
2 secondary outcomes
half life
Time frame: 14 days
Tmax
Time frame: 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Victoria Rodríguez, MD contact
Satish Kumar, MD principal investigator
Azidus Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Experimental Erythropoietin subcutaneous injection single dose of 4,000 IU and Active comparator Erythropoietin subcutaneous injection single dose of 4,000 IU in people with Healthy, run by Megalabs at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marcos Giusti, MD (+598926838000, mgiusti@megalabs.global), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of AUC0-inf (time frame: 14 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2024.