Reticulocyte CountPhase 1NCT02731469
Study of Pharmacokinetics, Pharmacodynamics, Safety of BCD-131 Compared to Mircera and Aranesp in Healthy Volunteers
A Phase 1 study testing BCD-131, Mircera® and Aranesp® in people with Reticulocyte Count, run by Biocad.
Trial summary
BCD-131-1 is an Open-Label Clinical Study of the Pharmacokinetics, Pharmacodynamics, Tolerability, Safety and Immunogenicity of Single Ascending Doses of BCD-131 in Healthy Volunteers Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Reticulocyte Count
- What is being tested?
- BCD-131, Mircera® and Aranesp®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2016to Mar 2017
- 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 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Signing of the Informed Consent Form;
- Male sex;
- Age of 18 to 45 years, inclusive;
- BMI within normal limits (18.5-24.9 kg/m2);
- Healthy patients, which is proved by their medical history, physical examination and laboratory findings:
- No clinically significant abnormalities of circulatory, respiratory, nervous, hematopoietic, endocrine and digestive systems, liver and kidneys in the past medical history and at screening;
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- No history of cardiovascular disorders or thyroid disorders;
- No history of hematologic disorders, including but not limited to any type of anemia, myelodysplastic syndrome, blood cancers, hemolytic syndrome, hemoglobinopathies, coagulopathies;
- CBC results within normal limits, including:
- Hemoglobin within 132-173 g/L;
- Hematocrit (based on CBC results) within 39-49%;
- Platelet count within 150-400*109/L;
- Absolute reticulocyte count within 30.4-93.5 * 109/L;
- Blood biochemistry and urinalysis results within normal limits;
- Serum ferritin within 20-250 µg/L;
- Serum endogenous erythropoietin within 4.3-29.0 MIU/mL;
- Hemodynamic parameters within normal limits: systolic blood pressure within 100-139 mmHg; diastolic blood pressure within 60-90 mmHg; heart rate within 50-90 bpm;
- No history of chronic infections (tuberculosis) or chronic inflammation;
- No hepatitis B or C, HIV, or syphilis;
- No acute infections within 4 weeks prior to inclusion in the study;
- No psychiatric disorders and other conditions (including depression) that can interfere with the volunteer's ability to follow the study protocol;
- Well-being (in the volunteer's opinion) within 30 days prior to inclusion in the study;
- No history of or current (at baseline) alcohol or drug abuse;
- Ability of the volunteer, in the investigator's opinion, to follow the study protocol procedures;
- Willingness of volunteers and their sexual partners with preserved reproductive potential to use reliable contraception within 2 weeks before inclusion in the study and up to 7 weeks after the injection of the test product. This criterion is not applicable to subjects who underwent surgical sterilization. Reliable methods of contraception include one barrier method in combination with one of the following methods: spermicides, intrauterine device/oral contraceptives (for sexual partners).
- Willingness of volunteers to avoid alcohol intake within 24 hours before and 8 days after each injection of the test drug;
Who cannot join
- History of treatment with erythropoietins or any other ESAs;
- Acute bleeding, blood/plasma donation or blood transfusion within 2 months before inclusion in the study;
- History of chronic bleeding;
- Standard laboratory and instrumental findings outside normal limits at screening;
- History of allergies (anaphylactic shock or multiple drug allergy syndrome);
- Known allergy or intolerance to any components of the investigational product;
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- Major surgery within 30 days prior to screening, or surgery being scheduled for any time during the study;
- Impossibility to install a venous catheter for blood sampling (e.g. because of skin disorders at the sites of venipuncture);
- Diseases or other conditions that can interfere with the pharmacokinetics of the investigational drug (e.g. chronic liver, kidney, blood, circulatory system, lung or neuroendocrine diseases, including diabetes mellitus and others);
- History of fever of 40 °C or more;
- History of elevated hepatic transaminases (above 2.5xULN);
- Episodes of thrombosis and/or thromboembolia in past medical history (myocardial infarction, stroke, transient ischemic attacks, deep vein thrombosis, pulmonary embolism within 6 months prior to inclusion in the study) as well as an increased risk of deep vein thrombosis;
- History of epileptic attacks or seizures;
- History or current (at screening) depression, suicidal thoughts/ attempts;
- Regular oral or parenteral use of any medications including over-the-counter drugs, vitamins and nutritional additives within 2 weeks before a scheduled injection of the test drug;
- Use of drugs, including OTC products, that significantly affect the hemodynamics, hepatic function, etc. (barbiturates, omeprazole, cimetidine, etc.) within 30 days before a scheduled injection of the test drug;
- Vaccination within 4 weeks before a scheduled injection of the test drug;
- Smoking more than 10 cigarettes per day;
- Consumption of more than 10 portions of alcohol per week (one portion equals to 0.5 L of beer, 200 mL of wine or 50 mL of ethanol) or a history of alcohol, drug or medication abuse;
- Participation in other clinical studies within 1 month before screening or simultaneous participation in another clinical study;
- Previous participation in this study.
About this study
Official title: Clinical Study of the Pharmacokinetics, Pharmacodynamics, Tolerability, Safety and Immunogenicity of BCD-131 Compared to Mircera and Aranesp in Healthy Volunteers
BCD-131-1 is an Open-Label Clinical Study of the Pharmacokinetics, Pharmacodynamics, Tolerability, Safety and Immunogenicity of Single Ascending Doses of BCD-131 in Healthy Volunteers
Read the detailed description
BCD-131 is novel drug product of pegylated darbepoetin alfa.
Clinical trial BCD-131-1 will be conducted in two stages:
Stage I is an open-label, non-randomized clinical study of pharmacokinetics, pharmacodynamics, tolerability, safety and immunogenicity of BCD-131 given to healthy volunteers at ascending doses (Phase 1, a traditional "3+3" design).
Also, the PK and PD parameters of the closest analogues of BCD-131 (Mircera and Aranesp) given as subcutaneous injections at therapeutic doses will be evaluated.
Stage II aims to further evaluate pharmacokinetics, pharmacodynamics and safety of subcutaneous and intravenous injections of BCD-131 at a dose which ensures PD effects similar to those of the closest analogues (Mircera, Aranesp) given as subcutaneous injections at therapeutic doses.
- Conditions
- Reticulocyte Count
- Being tested
- BCD-131, Mircera®, Aranesp®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCD-131Biological
Also called pegylated darbepoetin alfa
Mircera®Biological
Also called Methoxy polyethylene glycol-epoetin beta
Aranesp®Biological
Also called darbepoetin alfa
| Study group | Role | What they receive |
|---|---|---|
| BCD-131, 0.05 mcg/kg subcutaneously | Experimental | Healthy volunteers will receive BCD-131 in a dose 0.05 mcg/kg subcutaneously Receives: Biological: BCD-131 |
| BCD-131, 0.15 mcg/kg subcutaneously | Experimental | Healthy volunteers will receive BCD-131 in a dose 0.15 mcg/kg subcutaneously Receives: Biological: BCD-131 |
| BCD-131, 0.40 mcg/kg subcutaneously | Experimental | Healthy volunteers will receive BCD-131 in a dose 0.40 mcg/kg subcutaneously Receives: Biological: BCD-131 |
| BCD-131, 1.05 mcg/kg subcutaneously | Experimental | Healthy volunteers will receive BCD-131 in a dose 1.05 mcg/kg subcutaneously Receives: Biological: BCD-131 |
| BCD-131, 1.70 mcg/kg SC | Experimental | Healthy volunteers will receive BCD-131 in a dose 1.70 mcg/kg subcutaneously Receives: Biological: BCD-131 |
| BCD-131, 2.25 mcg/kg SC | Experimental | Healthy volunteers will receive BCD-131 in a dose 2.25 mcg/kg subcutaneously Receives: Biological: BCD-131 |
| BCD-131, 4.45 mcg/kg subcutaneously | Experimental | Healthy volunteers will receive BCD-131 in a dose 4.45 mcg/kg subcutaneously Receives: Biological: BCD-131 |
| Mircera®, 1.20 mcg/kg subcutaneously | Active comparator | Healthy volunteers will receive Mircera in a dose 1.20 mcg/kg subcutaneously Receives: Biological: Mircera® |
| Aranesp®, 0.45 mcg/kg subcutaneously | Active comparator | Healthy volunteers will receive BCD-131 in a dose 0.45 mcg/kg subcutaneously Receives: Biological: Aranesp® |
| BCD-131, optimal dose, intravenously | Experimental | Healthy volunteers will receive BCD-131 in optimal dose determined on first stage of clinical trial intravenously Receives: Biological: BCD-131 |
| BCD-131, optimal dose, subcutaneously | Experimental | Healthy volunteers will receive BCD-131 in optimal dose determined on first stage of clinical trial subcutaneously Receives: Biological: BCD-131 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC (0-1176 Hours)
Area under curve (AUC) "concentration - time" from 0 hours to 1176 hours and to infinity
Measured: 0, 15 min, 30 min; 60 min; 2 h, 4 h; 8 h, 24 h, 48 h, 72 h, 96 h, 120 h, 168 h, 216 h, 288 h, 336 h, 504 h, 672 h, 840 h, 1008 h, 1176 h post dose
Secondary outcomes (15)
Cmax
Maximal concentration of drug in blood after single injection
Measured: 0, 15 min, 30 min; 60 min; 2 h, 4 h; 8 h, 24 h, 48 h, 72 h, 96 h, 120 h, 168 h, 216 h, 288 h, 336 h, 504 h, 672 h, 840 h, 1008 h, 1176 hours post-dose
Tmax
Time from 9 hours to time of maximal concentration of drug in blood after single injection
Measured: 0, 15 min, 30 min; 60 min; 2 h, 4 h; 8 h, 24 h, 48 h, 72 h, 96 h, 120 h, 168 h, 216 h, 288 h, 336 h, 504 h, 672 h, 840 h, 1008 h, 1176 hours post-dose
T1/2
Half-life of drug in blood after single injection. In the coрort BCD-131 0,15 mcg/kg due to the absence of a linear terminal elimination phase in volunteers, the calculation of T1 / 2 was not possible
Measured: 0, 15 min, 30 min; 60 min; 2 h, 4 h; 8 h, 24 h, 48 h, 72 h, 96 h, 120 h, 168 h, 216 h, 288 h, 336 h, 504 h, 672 h, 840 h, 1008 h, 1176 hours post-dose
Kel
Elimination rate constant of drug in blood after single injection. In the cohort BCD-131 0,15 mcg/kg due to the absence of a linear terminal elimination phase in volunteers, the calculation of Kel was not possible
Measured: 0, 15 min, 30 min; 60 min; 2 h, 4 h; 8 h, 24 h, 48 h, 72 h, 96 h, 120 h, 168 h, 216 h, 288 h, 336 h, 504 h, 672 h, 840 h, 1008 h, 1176 hours post-dose
Clearance of BCD-131
Clearance of BCD-131 in blood after single injection
Measured: 0, 15 min, 30 min; 60 min; 2 h, 4 h; 8 h, 24 h, 48 h, 72 h, 96 h, 120 h, 168 h, 216 h, 288 h, 336 h, 504 h, 672 h, 840 h, 1008 h, 1176 hours post-dose
AUEC (0-1176 Hours) - Reticulocytes
Area under effect curve (AUEC) "absolute reticulocyte count - time" from 0 to 1176 hours post-dose after single injection of study drug
Measured: 0, 24 h, 48 h; 72 h; 96 h; 120 h; 168 h; 216 h; 288 h; 336 h, 504 h; 672 h; 840 h; 1008 h; 1176 h post-dose
AUEC (0-1176 Hours) - Hemoglobin
Area under effect curve (AUEC) "hemoglobin - time" from 0 to 1176 hours post-dose after single injection of study drug
Measured: 0, 24 h, 48 h; 72 h; 96 h; 120 h; 168 h; 216 h; 288 h; 336 h, 504 h; 672 h; 840 h; 1008 h; 1176 h post-dose
AC-Emax - Reticulocytes
Absolute maximum of reticulocyte count (AC-Emax - reticulocytes) after single injection of study drug
Measured: 0, 24 h, 48 h; 72 h; 96 h; 120 h; 168 h; 216 h; 288 h; 336 h, 504 h; 672 h; 840 h; 1008 h; 1176 h post-dose
AC-Emax - Hemoglobin
Absolute maximum of hemoglobin (AC-Emax - hemoglobin) after single injection of study drug
Measured: 0, 24 h, 48 h; 72 h; 96 h; 120 h; 168 h; 216 h; 288 h; 336 h, 504 h; 672 h; 840 h; 1008 h; 1176 h post-dose
Intensity of Pain After Subcutaneous Injection According to Visual Analog Scale
visual analog scale Minimum value - 0, Maximum value -10, Higher scores mean worse outcome
Measured: intraoperative
Number of Participants With Adverse Events and Serious Adverse Events
Total incidence of adverse events (AE)/ serious adverse events (SAE)
Measured: from the first administartion of the drug up to the end of follow up period (28 days after the last dose of the drug)
Number of Participants With Local Reactions
Incidence of administration site reactions
Measured: from the first administartion of the drug up to the end of follow up period (28 days after the last dose of the drug)
Number of Participants With AE/SAE 3-4 Grade CTCAE
Incidence of Grade 3-4 AEs and SAEs.
Measured: from the first administartion of the drug up to the end of follow up period (28 days after the last dose of the drug)
Number of Participants With Early Withdrawal Due to AE
Frequency of early withdrawals due to AEs and SAEs
Measured: from the first administartion of the drug up to the end of follow up period (28 days after the last dose of the drug)
Number of Participants With Binding Antibodies to BCD-131
Incidence of Binding antibodies to BCD-131 on Day 50 after a single injection of BCD-131
Measured: 0, day 50 post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2016 (estimated)
- Study start15 Jun 2016
- Primary completionMar 2017
- Study completionMar 2017
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 Reticulocyte CountStudies of the same condition, open and under way.
- More trials run by BiocadThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biocad
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Roman Ivanov, PhD, Study chair, JCS BIOCAD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02731469
- Sponsor's protocol ID
- BCD-131-1
- Status last verified
- Oct 2018
- First submitted
- 3 Apr 2016
- Last updated
- 1 Jul 2019
- 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 1 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of the Pharmacokinetics, Pharmacodynamics, Tolerability, Safety and Immunogenicity of BCD-131 Compared to Mircera and Aranesp in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02731469
- Acronym / sponsor ID
- BCD-131-1
- Conditions
- Reticulocyte Count
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- BiocadIndustry (pharma, biotech, devices)
- Study start
- 15 Jun 2016 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 7 Apr 2016 (estimated)
- Results
- Posted 1 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
BCD-131-1 is an Open-Label Clinical Study of the Pharmacokinetics, Pharmacodynamics, Tolerability, Safety and Immunogenicity of Single Ascending Doses of BCD-131 in Healthy Volunteers
Detailed description
BCD-131 is novel drug product of pegylated darbepoetin alfa.
Clinical trial BCD-131-1 will be conducted in two stages:
Stage I is an open-label, non-randomized clinical study of pharmacokinetics, pharmacodynamics, tolerability, safety and immunogenicity of BCD-131 given to healthy volunteers at ascending doses (Phase 1, a traditional "3+3" design).
Also, the PK and PD parameters of the closest analogues of BCD-131 (Mircera and Aranesp) given as subcutaneous injections at therapeutic doses will be evaluated.
Stage II aims to further evaluate pharmacokinetics, pharmacodynamics and safety of subcutaneous and intravenous injections of BCD-131 at a dose which ensures PD effects similar to those of the closest analogues (Mircera, Aranesp) given as subcutaneous injections at therapeutic doses.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 11
| Arm | Type | Receives |
|---|---|---|
| BCD-131, 0.05 mcg/kg subcutaneously | Experimental | Biological: BCD-131Healthy volunteers will receive BCD-131 in a dose 0.05 mcg/kg subcutaneously |
| BCD-131, 0.15 mcg/kg subcutaneously | Experimental | Biological: BCD-131Healthy volunteers will receive BCD-131 in a dose 0.15 mcg/kg subcutaneously |
| BCD-131, 0.40 mcg/kg subcutaneously | Experimental | Biological: BCD-131Healthy volunteers will receive BCD-131 in a dose 0.40 mcg/kg subcutaneously |
| BCD-131, 1.05 mcg/kg subcutaneously | Experimental | Biological: BCD-131Healthy volunteers will receive BCD-131 in a dose 1.05 mcg/kg subcutaneously |
| BCD-131, 1.70 mcg/kg SC | Experimental | Biological: BCD-131Healthy volunteers will receive BCD-131 in a dose 1.70 mcg/kg subcutaneously |
| BCD-131, 2.25 mcg/kg SC | Experimental | Biological: BCD-131Healthy volunteers will receive BCD-131 in a dose 2.25 mcg/kg subcutaneously |
| BCD-131, 4.45 mcg/kg subcutaneously | Experimental | Biological: BCD-131Healthy volunteers will receive BCD-131 in a dose 4.45 mcg/kg subcutaneously |
| Mircera®, 1.20 mcg/kg subcutaneously | Active comparator | Biological: Mircera®Healthy volunteers will receive Mircera in a dose 1.20 mcg/kg subcutaneously |
| Aranesp®, 0.45 mcg/kg subcutaneously | Active comparator | Biological: Aranesp®Healthy volunteers will receive BCD-131 in a dose 0.45 mcg/kg subcutaneously |
| BCD-131, optimal dose, intravenously | Experimental | Biological: BCD-131Healthy volunteers will receive BCD-131 in optimal dose determined on first stage of clinical trial intravenously |
| BCD-131, optimal dose, subcutaneously | Experimental | Biological: BCD-131Healthy volunteers will receive BCD-131 in optimal dose determined on first stage of clinical trial subcutaneously |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (26 listed)
- Signing of the Informed Consent Form;
- Male sex;
- Age of 18 to 45 years, inclusive;
- BMI within normal limits (18.5-24.9 kg/m2);
- Healthy patients, which is proved by their medical history, physical examination and laboratory findings:
Key exclusion criteria (21 listed)
- History of treatment with erythropoietins or any other ESAs;
- Acute bleeding, blood/plasma donation or blood transfusion within 2 months before inclusion in the study;
- History of chronic bleeding;
- Standard laboratory and instrumental findings outside normal limits at screening;
- History of allergies (anaphylactic shock or multiple drug allergy syndrome);
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 |
|---|---|---|
| BCD-131Also: pegylated darbepoetin alfa | Biological | BCD-131, 0.05 mcg/kg subcutaneously, BCD-131, 0.15 mcg/kg subcutaneously, BCD-131, 0.40 mcg/kg subcutaneously, BCD-131, 1.05 mcg/kg subcutaneously, BCD-131, 1.70 mcg/kg SC, BCD-131, 2.25 mcg/kg SC, BCD-131, 4.45 mcg/kg subcutaneously, BCD-131, optimal dose, intravenously, BCD-131, optimal dose, subcutaneously |
| Mircera®Also: Methoxy polyethylene glycol-epoetin beta | Biological | Mircera®, 1.20 mcg/kg subcutaneously |
| Aranesp®Also: darbepoetin alfa | Biological | Aranesp®, 0.45 mcg/kg subcutaneously |
Primary outcome
AUC (0-1176 Hours)
Time frame: 0, 15 min, 30 min; 60 min; 2 h, 4 h; 8 h, 24 h, 48 h, 72 h, 96 h, 120 h, 168 h, 216 h, 288 h, 336 h, 504 h, 672 h, 840 h, 1008 h, 1176 h post dose
Area under curve (AUC) "concentration - time" from 0 hours to 1176 hours and to infinity
15 secondary outcomes
Cmax
Time frame: 0, 15 min, 30 min; 60 min; 2 h, 4 h; 8 h, 24 h, 48 h, 72 h, 96 h, 120 h, 168 h, 216 h, 288 h, 336 h, 504 h, 672 h, 840 h, 1008 h, 1176 hours post-dose
Tmax
Time frame: 0, 15 min, 30 min; 60 min; 2 h, 4 h; 8 h, 24 h, 48 h, 72 h, 96 h, 120 h, 168 h, 216 h, 288 h, 336 h, 504 h, 672 h, 840 h, 1008 h, 1176 hours post-dose
T1/2
Time frame: 0, 15 min, 30 min; 60 min; 2 h, 4 h; 8 h, 24 h, 48 h, 72 h, 96 h, 120 h, 168 h, 216 h, 288 h, 336 h, 504 h, 672 h, 840 h, 1008 h, 1176 hours post-dose
Kel
Time frame: 0, 15 min, 30 min; 60 min; 2 h, 4 h; 8 h, 24 h, 48 h, 72 h, 96 h, 120 h, 168 h, 216 h, 288 h, 336 h, 504 h, 672 h, 840 h, 1008 h, 1176 hours post-dose
Clearance of BCD-131
Time frame: 0, 15 min, 30 min; 60 min; 2 h, 4 h; 8 h, 24 h, 48 h, 72 h, 96 h, 120 h, 168 h, 216 h, 288 h, 336 h, 504 h, 672 h, 840 h, 1008 h, 1176 hours post-dose
AUEC (0-1176 Hours) - Reticulocytes
Time frame: 0, 24 h, 48 h; 72 h; 96 h; 120 h; 168 h; 216 h; 288 h; 336 h, 504 h; 672 h; 840 h; 1008 h; 1176 h post-dose
AUEC (0-1176 Hours) - Hemoglobin
Time frame: 0, 24 h, 48 h; 72 h; 96 h; 120 h; 168 h; 216 h; 288 h; 336 h, 504 h; 672 h; 840 h; 1008 h; 1176 h post-dose
AC-Emax - Reticulocytes
Time frame: 0, 24 h, 48 h; 72 h; 96 h; 120 h; 168 h; 216 h; 288 h; 336 h, 504 h; 672 h; 840 h; 1008 h; 1176 h post-dose
AC-Emax - Hemoglobin
Time frame: 0, 24 h, 48 h; 72 h; 96 h; 120 h; 168 h; 216 h; 288 h; 336 h, 504 h; 672 h; 840 h; 1008 h; 1176 h post-dose
Intensity of Pain After Subcutaneous Injection According to Visual Analog Scale
Time frame: intraoperative
Number of Participants With Adverse Events and Serious Adverse Events
Time frame: from the first administartion of the drug up to the end of follow up period (28 days after the last dose of the drug)
Number of Participants With Local Reactions
Time frame: from the first administartion of the drug up to the end of follow up period (28 days after the last dose of the drug)
Number of Participants With AE/SAE 3-4 Grade CTCAE
Time frame: from the first administartion of the drug up to the end of follow up period (28 days after the last dose of the drug)
Number of Participants With Early Withdrawal Due to AE
Time frame: from the first administartion of the drug up to the end of follow up period (28 days after the last dose of the drug)
Number of Participants With Binding Antibodies to BCD-131
Time frame: 0, day 50 post-dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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.
Roman Ivanov, PhD study chair
JCS BIOCAD
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BCD-131, Mircera® and Aranesp® in people with Reticulocyte Count, run by Biocad.
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 26 inclusion and 21 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 1 Jul 2019. 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 1 Jul 2019). 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?
AUC (0-1176 Hours) (time frame: 0, 15 min, 30 min; 60 min; 2 h, 4 h; 8 h, 24 h, 48 h, 72 h, 96 h, 120 h, 168 h, 216 h, 288 h, 336 h, 504 h, 672 h, 840 h, 1008 h, 1176 h post dose). 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 1 Jul 2019.