AnemiaPhase 1NCT03822884
Pharmacokinetic/Pharmacodynamic Study of 3 Subcutaneous Single Dose Epoetin Alfa Formulations in Healthy Volunteers
A Phase 1 study testing Epoetin Alfa 40000 UNT/ML in people with Anemia, run by Bio Sidus SA.
Trial summary
Pharmacokinetic/Pharmacodynamic Study of 3 Epoetin Alfa Formulations in Single Subcutaneous Doses Administered to Healthy Volunteers SPONSOR Biosidus S.A. Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Anemia
- What is being tested?
- Epoetin Alfa 40000 UNT/ML
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to Dec 2016
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects of both sexes aged 21 - 55 years old.
- Baseline Hb levels between 11 and 14 in women and between 12 and 15 g/ dl in men.
- Body Mass Index (BMI) between 19 and 27 kg/ m2.
- Volunteers whose additional tests (ECG, blood, and urine), performed before their inclusion, are within the normal limits and/ or with no clinical significance based on the investigator's judgment. Women of childbearing potential should have a negative pregnancy test and use a safe contraceptive method during the study (UID or a similarly effective method).
- Subjects with systolic blood pressure higher than 100 mm Hg and lower than 139 mm Hg, diastolic blood pressure higher than 70 mm Hg and lower than 89 mm H, heart rate higher than 50 and lower than 90 heartbeats per minute after 5 minutes in sitting position and then in standing position (extreme values included).
- Volunteers who are well disposed to the study and have signed the approved informed consent before the beginning of the study.
Who cannot join
- History of clinically significant allergies (except untreated asymptomatic seasonal allergies).
- Decrease of more than 20 mm Hg in systolic blood pressure or more than 10 mm Hg in diastolic blood pressure within the first 3 minutes after the change in body position.
- Volunteers who are or have been taking other drugs (prescription or over - the - counter) within two weeks before the study.
- Volunteers with a history of autoimmune diseases.
- Organic CNS, psychological, or psychiatric disorders: epilepsy, manic - depressive tendencies, serious depressive episodes, insomnia, changes in personality.
- Active infections.
Show all 32Show fewer
- Having received live or killed virus or bacteria vaccines within a month before inclusion.
- Allergic to epoetin alfa or related substances, to human albumin, or any of the ingredients of the formulations.
- Previous exposure to recombinant epoetin.
- Active smoker (more than 10 cigarettes/ day).
- Current clinical evidence of severe digestive disorders.
- Current clinical evidence of kidney diseases.
- Current evidence of liver disorders.
- Current clinical evidence of respiratory or heart diseases.
- Diabetes mellitus, thyroid dysfunction, or other endocrine disorders.
- Evidence of active gastroduodenal disease.
- History of peripheral thrombotic events.
- An underlying neurological disorder.
- Current presence of a malignant disease.
- History of drug or alcohol abuse or addiction within the past three years.
- History of drug or alcohol abuse within the past two years.
- Participation in a clinical study within the past three months.
- A subject who donated or lost blood within three months before the beginning of the study, or who intends to donate blood within three months after the end of the study.
- Heavy drinker of tea, cocoa, mate, coffee, and/ or caffeinated drinks (> 5 cups/ day) or alcohol (> 50 ml/ day).
- Electrocardiogram abnormalities.
- Positive HIV, hepatitis B, or hepatitis C serological testing.
- Abnormal clinical laboratory results (considered as clinically significant by the physician).
- Volunteers who have received oral iron supplements within the last month.
- If Hb exceeds 18 g/ dl on the 504 - hour control before each treatment phase, confirmed by repetition of the analysis.
- Women who do not use an effective contraceptive method (IUD, condom).
- Pregnancy and breastfeeding.
- Uncooperative volunteer.
About this study
Pharmacokinetic/Pharmacodynamic Study of 3 Epoetin Alfa Formulations in Single Subcutaneous Doses Administered to Healthy Volunteers
SPONSOR Biosidus S.A.
Read the detailed description
TITLE
Pharmacokinetic/ Pharmacodynamic Study of 3 Epoetin Alfa Formulations in Single Subcutaneous Doses Administered to Healthy Volunteers
SPONSOR
Biosidus S.A.
PRINCIPAL INVESTIGATOR
Guillermo Di Girolamo, M.D., National License No. 56857, domiciled at Congreso 3137 (Calle 75), San Andrés (1651), Telephone/Fax: 4753 - 8211, e - mail: gdigirolamo@arnet.com.ar
CO-INVESTIGATORS
Guillermo Alberto Keller, M.D., National License No.106.860, domiciled at Murgiondo 376, CABA. Cell Phone: 1563615376 - e-mail: drguillermokeller@yahoo.com.ar
Paola Czerniuk, M.D., National License No. 84280, domiciled at Paraguay 3559, Piso 6, Dto A, CABA. Cell Phone 1550189563, e - mail: pczerniuk@intramed.net.ar SITE Centro de Medicina Integral S.R.L. - Address: Avenida Belgrano 1844, CABA (C1094) - Telephone: (011) 4383 - 5145
LABORATORY
Laboratorio de Calidad de Biosidus SA - Constitución 4234 (C1254ABX) Buenos Aires, Argentina - Tel. 4909 8000 - Fax 4909 8055
OBJECTIVES
Primary: To compare the pharmacokinetic and pharmacodynamic behavior of three formulations of epoetin alfa after subcutaneous administration of 40,000 UI:
- Erypo ® 40,000 UI, liquid without albumin, prefilled syringe, produced by Janssen - Cilag GmbH (Reference Formulation, "R")
- Hemax® 40,000 UI, lyophilized with albumin, vial, produced by Biosidus SA (Test Formulation Number 1, "T1")
- Hemax® PFS 40,000 UI, liquid without albumin, prefilled syringe, produced by Biosidus SA (Test Formulation Number 2, "T2")
Secondary: To assess the pharmacological action, through quantification of blood reticulocytes at different time points as a surrogate pharmacodynamic marker. Assessment of adverse effects and tolerance.
TRIAL DESIGN
Open, randomized, 3 - arm, cross - over, sequential, and balanced
DISCONTINUATION SCHEME
The sponsor and the investigators can independently discontinue the study at any time if there is a mere possibility of or in case of occurrence of a serious adverse effect or situation that might affect the volunteer's health. If the Hb exceeds 18 g/ dl confirmed by repetition of the analysis at the pre - dose control in each phase, the volunteer will be excluded and 1 unit of blood will be collected. If, after the procedure, it is still above 18 g/ dl, another 0.5 or 1 Unit of blood will be collected, based on medical judgment.
NUMBER OF VOLUNTEERS
24 (twenty - four) at first. Since it is a sequential design, if the statistical analysis of the first 24 volunteers does not show biosimilarity, 12 additional volunteers will be included up to a total of 36 (thirty - six) volunteers.
DURATION OF THE STUDY
3 months
Selection and recruitment period: 2 (two) months
TIME THE STUDY WILL TAKE
Visit I: Selecting volunteers, obtaining informed consents, performing baseline tests.
Visits II, III, and IV: They will consist of 3 hospitalization phases -one for subcutaneous administration of Test Formulation Number 1 (T1), another for subcutaneous administration of Test Formulation Number 2 (T2), and a third one for subcutaneous administration of Reference Formulation (R), with a washout period of no fewer than 28 days between phases.
Sampling times for erythropoietin quantification in each phase, carried out by Biosidus SA, will be: pre - dose and 1, 2, 4, 6, 7, 8, 9, 10, 11, 12, 15, 24, 48, 72, 96, and 120 hours post - dose.
Telephone contact: The Principal Investigator or the healthcare staff assigned by the Principal Investigator will contact the volunteer by phone after the volunteer's discharge until the last (120 - hour) outpatient collection in order to ask about tolerance to the medication and presence of adverse effects.
Blood samples will be collected for red blood cell, Hb, and reticulocyte counting using flow cytometry performed by Biosidus SA, as an erythropoietin surrogate pharmacodynamic marker at the following time points: pre - dose (0 hours), 24, 48, 72, 96, 120, and 240 hours.
Another blood sample will be collected for red blood cell and Hb count after 504 hours (21 days after the dose), 7 days before starting the next treatment cycle, in order to determine whether the volunteer complies with one of the inclusion criteria for the next phase, i.e. not exceeding 18 g/ dl of Hg.
DOSE / ROUTE / REGIME / OF THE INVESTIGATION PRODUCTS
Single 40,000 UI dose of epoetin alfa. The following formulations will be assessed after administering 1 subcutaneous injection on the arm:
- Erypo ® 40,000 UI, liquid without albumin, prefilled syringe, produced by Janssen - Cilag GmbH (Reference Formulation, "R")
- Hemax® 40,000 UI, lyophilized with albumin, vial, produced by Biosidus SA (Test Formulation Number 1, "T1")
- Hemax® PFS 40,000 UI, liquid without albumin, prefilled syringe, produced by Biosidus SA (Test Formulation Number 2, "T2")
There will be 6 randomly assigned sequences:
- R - T1 - T2
- R - T2 - T1
- T1 - R - T2
- T1 - T2 - R
- T2 - R - T1
- T2 - T1 - R
COMPARISON DRUG
Erypo ® 40,000 UI, liquid without albumin, prefilled syringe, produced by Janssen - Cilag GmbH (Reference Formulation, "R")
COMPARATIVE PHARMACOKINETIC AND PHARMACODYNAMIC ASSESSMENT BETWEEN THE FORMULATIONS
Based on the erythropoietin serum concentration results, at the different sampling times, the following variables will be calculated:
- AUC0 - 120h: Area under the serum concentration - time curve 0 - 120 h.
- AUC0 - ∞: Area under the serum concentration - time curve from time 0 extrapolated to infinity (∞).
- Cmax: Maximum serum concentration of erythropoietin.
- Cmin: Minimum serum concentration of erythropoietin.
- Tmax: Time to maximum serum concentration of erythropoietin.
The difference between Tmax times in each test formulations and the reference formulation will be assessed, and the elimination rate constant and half - life of the drug in the body will be calculated.
The average results for each formulation will be presented, as well as each volunteer's individual results.
STATISTICAL ANALYSIS
CALCULATION OF THE SAMPLE SIZE:
The size of the sample (n:24) was established based on literature data and information from absolute and relative bioavailability studies performed with the drug before by Biosidus SA. Since it is a sequential design, if the statistical analysis of the first 24 volunteers does not show biosimilarity, 12 additional volunteers will be included up to a total of 36 (thirty - six) volunteers.
ANALYSIS PLAN
COMPARATIVE PHARMACOKINETIC ANALYSIS BETWEEN FORMULATIONS
- AUCT / AUCR: Quotient between the area under the curve of the TEST formulation and the area under the curve of the REFERENCE. For the log transformation, the 90% confidence interval of the AUC ratio (for AUC0 - 120h and AUC0 - ∞) should be within the range of 0.80 - 1.25.
- CmaxT / CmaxR: Quotient between the Cmax of the Test formulation and the Cmax of the Reference. For the log transformation, the 90% confidence interval of the Cmax ratio should be within the range of 0.80 - 1.25.
COMPARATIVE PHARMACODYNAMIC ANALYSIS BETWEEN THE FORMULATIONS
- Maximum number of reticulocytesT / Maximum number of reticulocytesR: Quotient between the maximum number of reticulocytes in the Test formulation and the maximum number of reticulocytes in the Reference.
Using ANOVA, the possible differences between subjects, treatments, and periods will be analyzed.
Outliers: In order to determine possible outliers, a selective - statistical method will be applied.
- Conditions
- Anemia
- Being tested
- Epoetin Alfa 40000 UNT/ML
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epoetin Alfa 40000 UNT/MLDrug
Also called Hemax, Hemax PFS, Erypo
40.000 UI subcutaneous single dose
| Study group | Role | What they receive |
|---|---|---|
| Hemax® PFS 40,000 UI | Experimental | Epoetin Alfa 40000 UNT/ML subcutaneous single dose Receives: Drug: Epoetin Alfa 40000 UNT/ML |
| Hemax® 40,000 UI | Experimental | Epoetin Alfa 40000 UNT/ML subcutaneous single dose Receives: Drug: Epoetin Alfa 40000 UNT/ML |
| Erypo ® 40,000 UI | Active comparator | Epoetin Alfa 40000 UNT/ML subcutaneous single dose Receives: Drug: Epoetin Alfa 40000 UNT/ML |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-t
AUC0-t: Area under the serum concentration curve from time 0 to time t (in this case, 120 hours).
Measured: 120 h
AUC0-∞
AUC0-∞: Area under the serum concentration curve resulting from extrapolation from time 0 to time ∞.
Measured: 120hr
Cmax
Cmax: maximum serum concentration of epoetin alfa.
Measured: 120hr
Tmax
Tmax: time to the maximum serum concentration of epoetin alfa
Measured: 120hr
Secondary outcomes (4)
Reticulocyte Response: Cmax
Reticulocyte count by flow cytometry, as a surrogate marker of the pharmacodynamics of erythropoietin. Maximum reticulocyte concentration achieved.
Measured: 120hr
Reticulocyte Response: AUC 0-120h
Measured: 120hr
ADAs
Number of patients with antidrug antibodies after 3 months. Anti-erythropoietin antibodies screening was done using immunoprecipitation on the sample collected prior to the first dose of the first phase of the trial and on the 504-hour sample of the third phase
Measured: 120hr
Adverse Events
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Measured: 120hr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2019
- Study startSep 2016
- Primary completionSep 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AnemiaStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bio Sidus SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03822884
- Sponsor's protocol ID
- HMX.1.003
- Status last verified
- Jan 2019
- First submitted
- 11 Nov 2016
- Last updated
- 12 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic/Pharmacodynamic Study of 3 Subcutaneous Single Dose Epoetin Alfa Formulations in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03822884
- Acronym / sponsor ID
- HMX.1.003
- Conditions
- Anemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Bio Sidus SAIndustry (pharma, biotech, devices)
- Study start
- Sep 2016
- Primary completion
- Sep 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 30 Jan 2019 (actual)
- Results
- Posted 12 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pharmacokinetic/Pharmacodynamic Study of 3 Epoetin Alfa Formulations in Single Subcutaneous Doses Administered to Healthy Volunteers
SPONSOR Biosidus S.A.
Detailed description
TITLE
Pharmacokinetic/ Pharmacodynamic Study of 3 Epoetin Alfa Formulations in Single Subcutaneous Doses Administered to Healthy Volunteers
SPONSOR
Biosidus S.A.
PRINCIPAL INVESTIGATOR
Guillermo Di Girolamo, M.D., National License No. 56857, domiciled at Congreso 3137 (Calle 75), San Andrés (1651), Telephone/Fax: 4753 - 8211, e - mail: gdigirolamo@arnet.com.ar
CO-INVESTIGATORS
Guillermo Alberto Keller, M.D., National License No.106.860, domiciled at Murgiondo 376, CABA. Cell Phone: 1563615376 - e-mail: drguillermokeller@yahoo.com.ar
Paola Czerniuk, M.D., National License No. 84280, domiciled at Paraguay 3559, Piso 6, Dto A, CABA. Cell Phone 1550189563, e - mail: pczerniuk@intramed.net.ar SITE Centro de Medicina Integral S.R.L. - Address: Avenida Belgrano 1844, CABA (C1094) - Telephone: (011) 4383 - 5145
LABORATORY
Laboratorio de Calidad de Biosidus SA - Constitución 4234 (C1254ABX) Buenos Aires, Argentina - Tel. 4909 8000 - Fax 4909 8055
OBJECTIVES
Primary: To compare the pharmacokinetic and pharmacodynamic behavior of three formulations of epoetin alfa after subcutaneous administration of 40,000 UI:
- Erypo ® 40,000 UI, liquid without albumin, prefilled syringe, produced by Janssen - Cilag GmbH (Reference Formulation, "R")
- Hemax® 40,000 UI, lyophilized with albumin, vial, produced by Biosidus SA (Test Formulation Number 1, "T1")
- Hemax® PFS 40,000 UI, liquid without albumin, prefilled syringe, produced by Biosidus SA (Test Formulation Number 2, "T2")
Secondary: To assess the pharmacological action, through quantification of blood reticulocytes at different time points as a surrogate pharmacodynamic marker. Assessment of adverse effects and tolerance.
TRIAL DESIGN
Open, randomized, 3 - arm, cross - over, sequential, and balanced
DISCONTINUATION SCHEME
The sponsor and the investigators can independently discontinue the study at any time if there is a mere possibility of or in case of occurrence of a serious adverse effect or situation that might affect the volunteer's health. If the Hb exceeds 18 g/ dl confirmed by repetition of the analysis at the pre - dose control in each phase, the volunteer will be excluded and 1 unit of blood will be collected. If, after the procedure, it is still above 18 g/ dl, another 0.5 or 1 Unit of blood will be collected, based on medical judgment.
NUMBER OF VOLUNTEERS
24 (twenty - four) at first. Since it is a sequential design, if the statistical analysis of the first 24 volunteers does not show biosimilarity, 12 additional volunteers will be included up to a total of 36 (thirty - six) volunteers.
DURATION OF THE STUDY
3 months
Selection and recruitment period: 2 (two) months
TIME THE STUDY WILL TAKE
Visit I: Selecting volunteers, obtaining informed consents, performing baseline tests.
Visits II, III, and IV: They will consist of 3 hospitalization phases -one for subcutaneous administration of Test Formulation Number 1 (T1), another for subcutaneous administration of Test Formulation Number 2 (T2), and a third one for subcutaneous administration of Reference Formulation (R), with a washout period of no fewer than 28 days between phases.
Sampling times for erythropoietin quantification in each phase, carried out by Biosidus SA, will be: pre - dose and 1, 2, 4, 6, 7, 8, 9, 10, 11, 12, 15, 24, 48, 72, 96, and 120 hours post - dose.
Telephone contact: The Principal Investigator or the healthcare staff assigned by the Principal Investigator will contact the volunteer by phone after the volunteer's discharge until the last (120 - hour) outpatient collection in order to ask about tolerance to the medication and presence of adverse effects.
Blood samples will be collected for red blood cell, Hb, and reticulocyte counting using flow cytometry performed by Biosidus SA, as an erythropoietin surrogate pharmacodynamic marker at the following time points: pre - dose (0 hours), 24, 48, 72, 96, 120, and 240 hours.
Another blood sample will be collected for red blood cell and Hb count after 504 hours (21 days after the dose), 7 days before starting the next treatment cycle, in order to determine whether the volunteer complies with one of the inclusion criteria for the next phase, i.e. not exceeding 18 g/ dl of Hg.
DOSE / ROUTE / REGIME / OF THE INVESTIGATION PRODUCTS
Single 40,000 UI dose of epoetin alfa. The following formulations will be assessed after administering 1 subcutaneous injection on the arm:
- Erypo ® 40,000 UI, liquid without albumin, prefilled syringe, produced by Janssen - Cilag GmbH (Reference Formulation, "R")
- Hemax® 40,000 UI, lyophilized with albumin, vial, produced by Biosidus SA (Test Formulation Number 1, "T1")
- Hemax® PFS 40,000 UI, liquid without albumin, prefilled syringe, produced by Biosidus SA (Test Formulation Number 2, "T2")
There will be 6 randomly assigned sequences:
- R - T1 - T2
- R - T2 - T1
- T1 - R - T2
- T1 - T2 - R
- T2 - R - T1
- T2 - T1 - R
COMPARISON DRUG
Erypo ® 40,000 UI, liquid without albumin, prefilled syringe, produced by Janssen - Cilag GmbH (Reference Formulation, "R")
COMPARATIVE PHARMACOKINETIC AND PHARMACODYNAMIC ASSESSMENT BETWEEN THE FORMULATIONS
Based on the erythropoietin serum concentration results, at the different sampling times, the following variables will be calculated:
- AUC0 - 120h: Area under the serum concentration - time curve 0 - 120 h.
- AUC0 - ∞: Area under the serum concentration - time curve from time 0 extrapolated to infinity (∞).
- Cmax: Maximum serum concentration of erythropoietin.
- Cmin: Minimum serum concentration of erythropoietin.
- Tmax: Time to maximum serum concentration of erythropoietin.
The difference between Tmax times in each test formulations and the reference formulation will be assessed, and the elimination rate constant and half - life of the drug in the body will be calculated.
The average results for each formulation will be presented, as well as each volunteer's individual results.
STATISTICAL ANALYSIS
CALCULATION OF THE SAMPLE SIZE:
The size of the sample (n:24) was established based on literature data and information from absolute and relative bioavailability studies performed with the drug before by Biosidus SA. Since it is a sequential design, if the statistical analysis of the first 24 volunteers does not show biosimilarity, 12 additional volunteers will be included up to a total of 36 (thirty - six) volunteers.
ANALYSIS PLAN
COMPARATIVE PHARMACOKINETIC ANALYSIS BETWEEN FORMULATIONS
- AUCT / AUCR: Quotient between the area under the curve of the TEST formulation and the area under the curve of the REFERENCE. For the log transformation, the 90% confidence interval of the AUC ratio (for AUC0 - 120h and AUC0 - ∞) should be within the range of 0.80 - 1.25.
- CmaxT / CmaxR: Quotient between the Cmax of the Test formulation and the Cmax of the Reference. For the log transformation, the 90% confidence interval of the Cmax ratio should be within the range of 0.80 - 1.25.
COMPARATIVE PHARMACODYNAMIC ANALYSIS BETWEEN THE FORMULATIONS
- Maximum number of reticulocytesT / Maximum number of reticulocytesR: Quotient between the maximum number of reticulocytes in the Test formulation and the maximum number of reticulocytes in the Reference.
Using ANOVA, the possible differences between subjects, treatments, and periods will be analyzed.
Outliers: In order to determine possible outliers, a selective - statistical method will be applied.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hemax® PFS 40,000 UI | Experimental | Drug: Epoetin Alfa 40000 UNT/MLEpoetin Alfa 40000 UNT/ML subcutaneous single dose |
| Hemax® 40,000 UI | Experimental | Drug: Epoetin Alfa 40000 UNT/MLEpoetin Alfa 40000 UNT/ML subcutaneous single dose |
| Erypo ® 40,000 UI | Active comparator | Drug: Epoetin Alfa 40000 UNT/MLEpoetin Alfa 40000 UNT/ML subcutaneous single dose |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Subjects of both sexes aged 21 - 55 years old.
- Baseline Hb levels between 11 and 14 in women and between 12 and 15 g/ dl in men.
- Body Mass Index (BMI) between 19 and 27 kg/ m2.
- Volunteers whose additional tests (ECG, blood, and urine), performed before their inclusion, are within the normal limits and/ or with no clinical significance based on the investigator's judgment. Women of childbearing potential should have a negative pregnancy test and use a safe contraceptive method during the study (UID or a similarly effective method).
- Subjects with systolic blood pressure higher than 100 mm Hg and lower than 139 mm Hg, diastolic blood pressure higher than 70 mm Hg and lower than 89 mm H, heart rate higher than 50 and lower than 90 heartbeats per minute after 5 minutes in sitting position and then in standing position (extreme values included).
Key exclusion criteria (32 listed)
- History of clinically significant allergies (except untreated asymptomatic seasonal allergies).
- Decrease of more than 20 mm Hg in systolic blood pressure or more than 10 mm Hg in diastolic blood pressure within the first 3 minutes after the change in body position.
- Volunteers who are or have been taking other drugs (prescription or over - the - counter) within two weeks before the study.
- Volunteers with a history of autoimmune diseases.
- Organic CNS, psychological, or psychiatric disorders: epilepsy, manic - depressive tendencies, serious depressive episodes, insomnia, changes in personality.
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 Alfa 40000 UNT/MLAlso: Hemax, Hemax PFS, Erypo40.000 UI subcutaneous single dose | Drug | Erypo ® 40,000 UI, Hemax® 40,000 UI, Hemax® PFS 40,000 UI |
Primary outcome
AUC0-t
Time frame: 120 h
AUC0-t: Area under the serum concentration curve from time 0 to time t (in this case, 120 hours).
AUC0-∞
Time frame: 120hr
AUC0-∞: Area under the serum concentration curve resulting from extrapolation from time 0 to time ∞.
Cmax
Time frame: 120hr
Cmax: maximum serum concentration of epoetin alfa.
Tmax
Time frame: 120hr
Tmax: time to the maximum serum concentration of epoetin alfa
4 secondary outcomes
Reticulocyte Response: Cmax
Time frame: 120hr
Reticulocyte Response: AUC 0-120h
Time frame: 120hr
ADAs
Time frame: 120hr
Adverse Events
Time frame: 120hr
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Epoetin Alfa 40000 UNT/ML in people with Anemia, run by Bio Sidus SA.
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 32 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 12 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 12 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
AUC0-t (time frame: 120 h). 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 12 Feb 2020.