HealthyPhase 1NCT01685359
PK and PD Parallel Study After Multiple Dose, Intravenous Administration of Two Epoetin Alfa, Human Recombinant
A Phase 1 study testing Epoetin Alfa in people with Healthy, run by Azidus Brasil at 1 site in Brazil.
Trial summary
The hypothesis of this trial is that the test drug (Human Recombiant Epoetin - Blau) pharmacokinetics and pharmacodynamics parameters are similar to the comparator drug (Eprex ® - Janssen-Cilag) in healthy subjects following administration of multiple intravenous dose. Read more about this study
- Who is it for?
- Ages 20 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Epoetin Alfa
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteBrazil
- Study dates
- 28 Feb 2013to 31 Oct 2013
- 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 20 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Agree to all the purposes of the study by signing and dating the Informed Consent;
- Male, aged between 20 and 55 years, clinically healthy;
- BMI between 18.5 and 30;
- Hemoglobin between 13.8 and 15.4 g / dL and hematocrit between 41% and 49%;
- VCM between 82 and 98, HBMC between 26 and 34, platelets between 150,000 and 400,000 units per mL. and WBC between 3,500 to 10,500 units per ml and no atypical cells.
- Human serum ferritin between 36-262 mcg / L;
- Counting of reticulocytes in peripheral blood ≤ 3%;
- Serum erythropoietin < 30 mIU / mL.
Who cannot join
- Participation in clinical trials in the 12 months preceding the survey;
- Body weight > 100 kg;
- Presence of iron deficiency anemia;
- Presence of pulmonary, cardiovascular, neurological, endocrine, gastrointestinal, genitourinary or other systems diseases;
- Acute disease in the period of 07 days before the beginning of the practical phase (administration of the drug) of the study;
- Chronic administration of medications for hypertension, diabetes or any other disease that requires continuous use of any drug;
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- Hormone therapy in the period of 02 months preceding the beginning of the practical phase (administration of the drug) of the study;
- Administration of any drug in the 02 weeks prior to the start of the practical period of the study;
- Clinical history of autoimmune or hereditary anemia;
- Clinical history of chronic bleeding;
- Clinical history of acute bleeding in the 30 days preceding the beginning of practical phase of the study (administration of the drug);
- Clinical history of allergy of biological products derived from mammalian albumin or any component of the formulation;
- Current or previous history (less than 12 months) of illicit drug abuse and / or tobacco and / or alcohol or having consumed alcohol within 48 hours prior to the practical study periods (administration of the drug);
- Prior therapies with erythropoietin;
- Albumin below 3.5 g/dL or higher than 4.8 g/dL;
- Signs or clinical history of bone marrow aplasia;
- History and clinical or laboratory liver disease;
- History and clinical or laboratory nephropathy;
- Principal Investigator of the study criteria.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1 Assessment of Pharmacokinetics and Pharmacodynamics of Two Epoetin Alfa, Human Recombinant Epoetin (Blau Farmacêutica) and Eprex (Janssen-Cilag), After Multiple Dose, Intravenous Administration in Healthy Subjects: a Randomized Parallel Study.
The hypothesis of this trial is that the test drug (Human Recombiant Epoetin - Blau) pharmacokinetics and pharmacodynamics parameters are similar to the comparator drug (Eprex ® - Janssen-Cilag) in healthy subjects following administration of multiple intravenous dose. The objective of this randomized, parallel, clinical trial is to evaluate the pharmacokinetic and pharmacodynamic profile of the test drug Human Reconbiant Epoetin produced by Blau Farmacêutica, compared to the comparator drug Eprex®, produced by Janssen-Cilag, by assessing plasma concentration of the drug and the reticulocyte count following a multiple intravenous administration during 4 weeks of 100 IU/kg in healthy subjects.
- Conditions
- Healthy
- Being tested
- Epoetin Alfa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epoetin AlfaDrug
Also called Eprex
Intravenous administration for 4 weeks, three times a week (monday, wednesday, friday)
| Study group | Role | What they receive |
|---|---|---|
| Test Drug | Experimental | Test Drug (Human Recombinant Epoetin alfa - Blau) dosage: 100 IU/kg intravenous administration Receives: Drug: Epoetin Alfa |
| Eprex | Active comparator | Eprex (Janssen-Cilag, Epoetin alfa) dosage: 100 IU/kg intravenous administration Receives: Drug: Epoetin Alfa |
What is being measured
The primary outcome is the main question the study is designed to answer.
rHuEPO Serum Concentration
Time frame on days 1, 8, 19 and 22: -10min, 0h, 5min, 15min, 30min, 45min, 1,5h, 2h, 3h, 4h, 5h, 6h, 8h, 10h and 12h after administration;
Time frame on day 26: -10min, 0h, 5min, 15min, 30min, 45min, 1,5h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h and 36h after last drug administration.
Measured: 1, 8, 15, 19, 22 and 26 days after first administration
Plasma reticulocyte count
Time frame on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24 and 26: 10 minutes before drug administration.
Time frameon day 29: 72h +/- 2h after last drug administration.
Measured: 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26 and 29 days after first administration of the drug.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2012 (estimated)
- Study start28 Feb 2013
- Primary completion31 Oct 2013
- Study completion31 Oct 2013
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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azidus Brasil
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01685359
- Sponsor's protocol ID
- EPOBLA0612IV-I2
- Other IDs
- Version 1 25/06/2012
- Status last verified
- Oct 2022
- First submitted
- 26 Jul 2012
- Last updated
- 28 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Assessment of Pharmacokinetics and Pharmacodynamics of Two Epoetin Alfa, Human Recombinant Epoetin (Blau Farmacêutica) and Eprex (Janssen-Cilag), After Multiple Dose, Intravenous Administration in Healthy Subjects: a Randomized Parallel Study.
- ClinicalTrials.gov ID
- NCT01685359
- Acronym / sponsor ID
- EPOBLA0612IV-I2
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Azidus BrasilIndustry (pharma, biotech, devices)
- Study start
- 28 Feb 2013 (actual)
- Primary completion
- 31 Oct 2013 (actual)
- Study completion
- 31 Oct 2013 (actual)
- First posted
- 14 Sep 2012 (estimated)
- 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.
The hypothesis of this trial is that the test drug (Human Recombiant Epoetin - Blau) pharmacokinetics and pharmacodynamics parameters are similar to the comparator drug (Eprex ® - Janssen-Cilag) in healthy subjects following administration of multiple intravenous dose. The objective of this randomized, parallel, clinical trial is to evaluate the pharmacokinetic and pharmacodynamic profile of the test drug Human Reconbiant Epoetin produced by Blau Farmacêutica, compared to the comparator drug Eprex®, produced by Janssen-Cilag, by assessing plasma concentration of the drug and the reticulocyte count following a multiple intravenous administration during 4 weeks of 100 IU/kg in healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Drug | Experimental | Drug: Epoetin AlfaTest Drug (Human Recombinant Epoetin alfa - Blau) dosage: 100 IU/kg intravenous administration |
| Eprex | Active comparator | Drug: Epoetin AlfaEprex (Janssen-Cilag, Epoetin alfa) dosage: 100 IU/kg intravenous administration |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Agree to all the purposes of the study by signing and dating the Informed Consent;
- Male, aged between 20 and 55 years, clinically healthy;
- BMI between 18.5 and 30;
- Hemoglobin between 13.8 and 15.4 g / dL and hematocrit between 41% and 49%;
- VCM between 82 and 98, HBMC between 26 and 34, platelets between 150,000 and 400,000 units per mL. and WBC between 3,500 to 10,500 units per ml and no atypical cells.
Key exclusion criteria (19 listed)
- Participation in clinical trials in the 12 months preceding the survey;
- Body weight > 100 kg;
- Presence of iron deficiency anemia;
- Presence of pulmonary, cardiovascular, neurological, endocrine, gastrointestinal, genitourinary or other systems diseases;
- Acute disease in the period of 07 days before the beginning of the practical phase (administration of the drug) of the study;
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 |
|---|---|---|
| Epoetin AlfaAlso: EprexIntravenous administration for 4 weeks, three times a week (monday, wednesday, friday) | Drug | Eprex, Test Drug |
Primary outcome
rHuEPO Serum Concentration
Time frame: 1, 8, 15, 19, 22 and 26 days after first administration
Time frame on days 1, 8, 19 and 22: -10min, 0h, 5min, 15min, 30min, 45min, 1,5h, 2h, 3h, 4h, 5h, 6h, 8h, 10h and 12h after administration; Time frame on day 26: -10min, 0h, 5min, 15min, 30min, 45min, 1,5h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h and 36h after last drug administration.
Plasma reticulocyte count
Time frame: 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26 and 29 days after first administration of the drug.
Time frame on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24 and 26: 10 minutes before drug administration. Time frameon day 29: 72h +/- 2h after last drug administration.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Epoetin Alfa in people with Healthy, run by Azidus Brasil at 1 site in Brazil.
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 8 inclusion and 19 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: finished, as of the sponsor's last update on 28 Oct 2022. 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 Brazil. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rHuEPO Serum Concentration (time frame: 1, 8, 15, 19, 22 and 26 days after first administration). The study lists 2 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 28 Oct 2022; AzTrials last refreshed its copy on 2 Nov 2026.