Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
BCD-066 is a darbepoetin alfa. Clinical study BCD-066-3 is a double-blind controlled, randomized, parallel-group study of the pharmacokinetics, pharmacodynamics, tolerability, and safety of multiple intravenous injections of BCD-066 and Aranesp®.
The purpose of the study is to confirm the equivalent pharmacokinetics, pharmacodynamics, safety, and tolerability of multiple IV injections of BCD-066 and Aranesp® in healthy volunteers.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BCD-066 1 µg/kg | Experimental | Healthy volunteers will receive BCD-066 1 μg/kg as weekly IV injections on Day 1, Day 8, Day 15, and Day 22. |
|
| Aranesp 1 µg/kg | Active Comparator | Healthy volunteers will receive Aranesp 1 μg/kg as weekly IV injections on Day 1, Day 8, Day 15, and Day 22. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BCD-066 | Biological | BCD-066 will be administered once a week intravenously in a dose 1 µg/kg |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUC(0-72) | The area concentration curve for darbepoetin alfa from injection to 72 h (AUC(0-72) after the first and the fourth IV injection of BCD-066 or Aranesp | 5 min, 10 min, 15 min, 20 min, 30 min, 45 min, 1 h, 2 h, 4 h, 8 h, 16 h, 24 h, 48 h, 72 h post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | The maximum concentration of darbepoetin alfa in the serum after the first and the fourth IV injection of BCD-066 or Aranesp® | 5 min, 10 min, 15 min, 20 min, 30 min, 45 min, 1 h, 2 h, 4 h, 8 h, 16 h, 24 h, 48 h, 72 h post-dose post-dose |
| T½ |
Not provided
Inclusion Criteria:
Exclusion Criteria:
1. Psychiatric disorders or other conditions that can affect the ability of the subject to follow the study protocol 2. Acute infections within 4 weeks before the study start 3. Results of laboratory and/or instrumental tests are outside the normal range 4. Chronic cardiovascular, bronchial and/or pulmonary, neuroendocrine GI, liver, kidney, and blood diseases, including ischemic heart disease, arterial hypertension, peripheral vascular and/or cerebral vascular disorders, and thrombocytosis 5. A history of chronic hemorrhages
-
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Roman Ivanov, PhD | JCS BIOCAD | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BIOCAD | Saint Petersburg | Strelna | 198515 | Russia |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | BCD-066 1 µg/kg | Healthy volunteers will receive BCD-066 1 μg/kg as weekly IV injections on Day 1, Day 8, Day 15, and Day 22. BCD-066: BCD-066 will be administered once a week intravenously in a dose 1 µg/kg |
| FG001 | Aranesp 1 µg/kg | Healthy volunteers will receive Aranesp 1 μg/kg as weekly IV injections on Day 1, Day 8, Day 15, and Day 22. Aranesp: Aranesp will be administered once a week intravenously in a dose 1 µg/kg |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | BCD-066 1 µg/kg | Healthy volunteers will receive BCD-066 1 μg/kg as weekly IV injections on Day 1, Day 8, Day 15, and Day 22. BCD-066: BCD-066 will be administered once a week intravenously in a dose 1 µg/kg |
| BG001 | Aranesp 1 µg/kg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | AUC(0-72) | The area concentration curve for darbepoetin alfa from injection to 72 h (AUC(0-72) after the first and the fourth IV injection of BCD-066 or Aranesp | Posted | Median | Inter-Quartile Range | pg/ml·h | 5 min, 10 min, 15 min, 20 min, 30 min, 45 min, 1 h, 2 h, 4 h, 8 h, 16 h, 24 h, 48 h, 72 h post-dose |
|
AEs where collected from the first drug administration (visit 1, day 1) till the end of follow-up period (4 weeks after the last administration of the drug (day 50)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BCD-066 1 µg/kg | Healthy volunteers will receive BCD-066 1 μg/kg as weekly IV injections on Day 1, Day 8, Day 15, and Day 22. BCD-066: BCD-066 will be administered once a week intravenously in a dose 1 µg/kg |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| monocytes count increase | Blood and lymphatic system disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Yulia Linkova Medical Director | BIOCAD | +7 (495) 992 66 28 ext. 930 | linkova@biocad.ru |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 2, 2016 | Oct 1, 2018 | SAP_001.pdf |
| Prot | Yes | No | No | Study Protocol | Oct 2, 2016 | Apr 8, 2019 | Prot_003.pdf |
Not provided
| ID | Term |
|---|---|
| D000068256 | Darbepoetin alfa |
| ID | Term |
|---|---|
| D004921 | Erythropoietin |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Aranesp | Biological | Aranesp will be administered once a week intravenously in a dose 1 µg/kg |
|
|
The elimination half-life
| 5 min, 10 min, 15 min, 20 min, 30 min, 45 min, 1 h, 2 h, 4 h, 8 h, 16 h, 24 h, 48 h, 72 h post-dose |
| AUC(0-∞) | The total area under the concentration curve from 0 to infinity | 5 min, 10 min, 15 min, 20 min, 30 min, 45 min, 1 h, 2 h, 4 h, 8 h, 16 h, 24 h, 48 h, 72 h post-dose |
| Tmax | The time to maximum drug concentration in the serum | 5 min, 10 min, 15 min, 20 min, 30 min, 45 min, 1 h, 2 h, 4 h, 8 h, 16 h, 24 h, 48 h, 72 h post-dose |
| Kel | The elimination constant: kel=1/MRT, where MRT is median residence time: MRT=AUMC(0-72)/AUC(0-72) | 5 min, 10 min, 15 min, 20 min, 30 min, 45 min, 1 h, 2 h, 4 h, 8 h, 16 h, 24 h, 48 h, 72 h post-dose |
| CL | The total clearance | 5 min, 10 min, 15 min, 20 min, 30 min, 45 min, 1 h, 2 h, 4 h, 8 h, 16 h, 24 h, 48 h, 72 h post-dose |
Healthy volunteers will receive Aranesp 1 μg/kg as weekly IV injections on Day 1, Day 8, Day 15, and Day 22.
Aranesp: Aranesp will be administered once a week intravenously in a dose 1 µg/kg
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| Secondary | Cmax | The maximum concentration of darbepoetin alfa in the serum after the first and the fourth IV injection of BCD-066 or Aranesp® | Posted | Median | Inter-Quartile Range | pg/ml | 5 min, 10 min, 15 min, 20 min, 30 min, 45 min, 1 h, 2 h, 4 h, 8 h, 16 h, 24 h, 48 h, 72 h post-dose post-dose |
|
|
|
| Secondary | T½ | The elimination half-life | Posted | Median | Inter-Quartile Range | hours | 5 min, 10 min, 15 min, 20 min, 30 min, 45 min, 1 h, 2 h, 4 h, 8 h, 16 h, 24 h, 48 h, 72 h post-dose |
|
|
|
| Secondary | AUC(0-∞) | The total area under the concentration curve from 0 to infinity | Posted | Median | Inter-Quartile Range | pg/ml·h | 5 min, 10 min, 15 min, 20 min, 30 min, 45 min, 1 h, 2 h, 4 h, 8 h, 16 h, 24 h, 48 h, 72 h post-dose |
|
|
|
| Secondary | Tmax | The time to maximum drug concentration in the serum | Posted | Median | Inter-Quartile Range | hours | 5 min, 10 min, 15 min, 20 min, 30 min, 45 min, 1 h, 2 h, 4 h, 8 h, 16 h, 24 h, 48 h, 72 h post-dose |
|
|
|
| Secondary | Kel | The elimination constant: kel=1/MRT, where MRT is median residence time: MRT=AUMC(0-72)/AUC(0-72) | Posted | Median | Inter-Quartile Range | fraction of drug per hour | 5 min, 10 min, 15 min, 20 min, 30 min, 45 min, 1 h, 2 h, 4 h, 8 h, 16 h, 24 h, 48 h, 72 h post-dose |
|
|
|
| Secondary | CL | The total clearance | Posted | Median | Inter-Quartile Range | ml/h | 5 min, 10 min, 15 min, 20 min, 30 min, 45 min, 1 h, 2 h, 4 h, 8 h, 16 h, 24 h, 48 h, 72 h post-dose |
|
|
|
| 0 |
| 28 |
| 0 |
| 28 |
| 5 |
| 28 |
| EG001 | Aranesp 1 µg/kg | Healthy volunteers will receive Aranesp 1 μg/kg as weekly IV injections on Day 1, Day 8, Day 15, and Day 22. Aranesp: Aranesp will be administered once a week intravenously in a dose 1 µg/kg | 0 | 28 | 0 | 28 | 16 | 28 |
| thrombocytes count increase | Blood and lymphatic system disorders | Systematic Assessment |
|
| Hematocrit decrease | Blood and lymphatic system disorders | Systematic Assessment |
|
| Hemoglobin decrease | Blood and lymphatic system disorders | Systematic Assessment |
|
| WBC decrease | Blood and lymphatic system disorders | Systematic Assessment |
|
| Neutrophis count decrease | Blood and lymphatic system disorders | Systematic Assessment |
|
| RBC decrease | Blood and lymphatic system disorders | Systematic Assessment |
|
Not provided
Not provided
| D002241 |
| Carbohydrates |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |