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BCD-002-1 is 1 phase clinical trial to evaluate pharmacokinetics, pharmacodynamics and safety of single-injection of Leucostim® to healthy volunteers compared to Neupogen®
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Leucostim® --> Neupogen®, subcutaneous injections | Experimental | Healthy volunteers in this group will receive single subcutaneous injection Leucostim® on Day 1 followed by single subcutaneous injection Leucostim® on Day 29. |
|
| Neupogen® --> Leucostim®, subcutaneous injections | Experimental | Healthy volunteers in this group will receive single subcutaneous injection Neupogen®, on Day 1 followed by single subcutaneous injection Leucostim® on Day 29. |
|
| Leucostim® --> Neupogen®, intravenous injections | Experimental | Healthy volunteers in this group will receive single intravenous injection Leucostim® on Day 1 followed by single intravenous injection Leucostim® on Day 29. |
|
| Neupogen® --> Leucostim®, intravenous injections | Experimental | Healthy volunteers in this group will receive single intravenous injection Neupogen® on Day 1 followed by single subcutaneous intravenous Leucostim® on Day 29. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Leucostim® | Biological | Leucostim® is filgrastim biosimilar. |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUC (0-48 Hours) | Area Under Curve (AUC) "concentration - time" from the moment of filgrastim injection to 48 hours | 0 to 48 hours post-dose |
| Cmax After Subcutaneous Injection | Maximal concentration of filgrastim after subcutaneous injection of filgrastim | 0 to 48 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax After Intravenous Injection | Maximal concentration of filgrastim after intravenous injection of filgrastim | 0 to 48 hours post-dose |
| Tmax After Injection | Time after single injection to reach maximal concentration of filgrastim |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roman Ivanov, PhD | JCS BIOCAD | Study Chair |
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| ID | Title | Description |
|---|---|---|
| FG000 | Leucostim® --> Neupogen®, Subcutaneous Injections | Healthy volunteers in this group received single subcutaneous injection Leucostim® on Day 1 followed by single subcutaneous injection Leucostim® on Day 29. Leucostim®: Leucostim® is filgrastim biosimilar. Neupogen® |
| FG001 | Neupogen® --> Leucostim®, Subcutaneous Injections | Healthy volunteers in this group received single subcutaneous injection Neupogen®, on Day 1 followed by single subcutaneous injection Leucostim® on Day 29. Leucostim®: Leucostim® is filgrastim biosimilar. Neupogen® |
| FG002 | Leucostim® --> Neupogen®, Intravenous Injections | Healthy volunteers in this group received single intravenous injection Leucostim® on Day 1 followed by single intravenous injection Leucostim® on Day 29. Leucostim®: Leucostim® is filgrastim biosimilar. Neupogen® |
| FG003 | Neupogen® --> Leucostim®, Intravenous Injections | Healthy volunteers in this group received single intravenous injection Neupogen® on Day 1 followed by single subcutaneous intravenous Leucostim® on Day 29. Leucostim®: Leucostim® is filgrastim biosimilar. Neupogen® |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Leucostim® --> Neupogen®, Subcutaneous Injections | Healthy volunteers in this group received single subcutaneous injection Leucostim® on Day 1 followed by single subcutaneous injection Leucostim® on Day 29. Leucostim®: Leucostim® is filgrastim biosimilar. Neupogen® |
| BG001 | Neupogen® --> Leucostim®, Subcutaneous Injections |
| 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 (0-48 Hours) | Area Under Curve (AUC) "concentration - time" from the moment of filgrastim injection to 48 hours | Posted | Geometric Mean | Standard Deviation | picogram per ml / hour | 0 to 48 hours post-dose |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Leucostim®, Subcutaneous Injections | Healthy volunteers in this group received single subcutaneous injection Leucostim® on Day 1(in group Leucostim®-->Neupogen®) or single subcutaneous injection Leucostim® on Day 29 (in group Neupogen® --> Leucostim®) Leucostim®: Leucostim® is filgrastim biosimilar. Neupogen® |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphocytosis | Blood and lymphatic system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Yulia Linkova Medical Director | Biocad | +7 (495) 992 66 28 | 930 | linkova@biocad.ru |
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| ID | Term |
|---|---|
| D007964 | Leukocytosis |
| ID | Term |
|---|---|
| D007960 | Leukocyte Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D000069585 | Filgrastim |
| ID | Term |
|---|---|
| D016179 | Granulocyte Colony-Stimulating Factor |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
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|
| Neupogen® | Biological |
|
|
| 0 to 48 hours post-dose |
| Т½ | Half-life of filgrastim after single injection of filgrastim | 0 to 48 hours post-dose |
| Kel | The elimination rate constant after single injection of filgrastim | 0 to 48 hours post-dose |
| Clearance | Clearance of filgrastim after single injection | 0 to 48 hours post-dose |
| ANC-AUEC (0-336 Hours) | Area Under Effect Curve (AUEC) "effect - time" from the moment of filgrastim injection to 336 hours based on absolute neutrophil count (ANC) | 0 to 336 hours post-dose |
| ANC-Emax | Maximal absolute neutrophil count after single filgrastim injection | 0 to 336 hours post-dose |
| CD34-AUEC (0-336 Hours) | Area Under Effect Curve (AUEC) "effect - time" from the moment of filgrastim injection to 336 hours based on CD-34 cells count (CD34) | 0 to 336 hours post-dose |
| CD34-Emax | Maximal absolute count of CD34-cells after single filgrastim injection | 0 to 336 hours post-dose |
| Overall Frequency of Serious Adverse Events (SAE) | 0 to 336 hours post-dose |
| Overall Frequency of Adverse Events (AE) | 0 to 336 hours post-dose |
| Frequency of Local Reactions | 0 to 336 hours post-dose |
| Frequency of AE/SAE 3-4 Grade CTCAE 4.03 | Grading scale of CTCAE 4.03 Grade refers to the severity of the AE. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE: Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL (activities of daily living). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE. | 0 to 336 hours post-dose |
| Frequency of Preliminary Withdrawal Due to AE/SAE | 0 to 336 hours post-dose |
| Proportion of Patients With Binding or Neutralizing Antibodies to Filgrastim | Proportion of patients who had developed binding or neutralizing antibodies to filgrastim after single injection. | 0 to 336 hours post-dose |
Healthy volunteers in this group received single subcutaneous injection Neupogen®, on Day 1 followed by single subcutaneous injection Leucostim® on Day 29. Leucostim®: Leucostim® is filgrastim biosimilar. Neupogen® |
| BG002 | Leucostim® --> Neupogen®, Intravenous Injections | Healthy volunteers in this group received single intravenous injection Leucostim® on Day 1 followed by single intravenous injection Leucostim® on Day 29. Leucostim®: Leucostim® is filgrastim biosimilar. Neupogen® |
| BG003 | Neupogen® --> Leucostim®, Intravenous Injections | Healthy volunteers in this group received single intravenous injection Neupogen® on Day 1 followed by single subcutaneous intravenous Leucostim® on Day 29. Leucostim®: Leucostim® is filgrastim biosimilar. Neupogen® |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| OG002 | Leucostim® Intravenous Injections | Healthy volunteers in this group received single intravenous injection Leucostim® on Day 1 (in Leucostim® --> Neupogen® group) or single intravenous injection Leucostim® on Day 29 (in Neupogen®--> Leucostim® group) Leucostim®: Leucostim® is filgrastim biosimilar. Neupogen® |
| OG003 | Neupogen® Intravenous Injections | Healthy volunteers in this group received single intravenous injection Neupogen® on Day 1 (in Neupogen® --> Leucostim® group) or subcutaneous intravenous Leucostim® on Day 29 (in Leucostim®-->Neupogen® group) Leucostim®: Leucostim® is filgrastim biosimilar. Neupogen® |
|
|
| Primary | Cmax After Subcutaneous Injection | Maximal concentration of filgrastim after subcutaneous injection of filgrastim | Posted | Geometric Mean | Standard Deviation | picogram per ml | 0 to 48 hours post-dose |
|
|
|
| Secondary | Cmax After Intravenous Injection | Maximal concentration of filgrastim after intravenous injection of filgrastim | Posted | Geometric Mean | Standard Deviation | picogram per ml | 0 to 48 hours post-dose |
|
|
|
| Secondary | Tmax After Injection | Time after single injection to reach maximal concentration of filgrastim | Posted | Median | Inter-Quartile Range | hours | 0 to 48 hours post-dose |
|
|
|
| Secondary | Т½ | Half-life of filgrastim after single injection of filgrastim | Posted | Median | Inter-Quartile Range | hours | 0 to 48 hours post-dose |
|
|
|
| Secondary | Kel | The elimination rate constant after single injection of filgrastim | Posted | Mean | Inter-Quartile Range | hour-1 | 0 to 48 hours post-dose |
|
|
|
| Secondary | Clearance | Clearance of filgrastim after single injection | Posted | Median | Inter-Quartile Range | ml per hour | 0 to 48 hours post-dose |
|
|
|
| Secondary | ANC-AUEC (0-336 Hours) | Area Under Effect Curve (AUEC) "effect - time" from the moment of filgrastim injection to 336 hours based on absolute neutrophil count (ANC) | Posted | Geometric Mean | Standard Deviation | cells х10^9 per liter/hour | 0 to 336 hours post-dose |
|
|
|
| Secondary | ANC-Emax | Maximal absolute neutrophil count after single filgrastim injection | Posted | Geometric Mean | Standard Deviation | cells х10^9 per liter | 0 to 336 hours post-dose |
|
|
|
| Secondary | CD34-AUEC (0-336 Hours) | Area Under Effect Curve (AUEC) "effect - time" from the moment of filgrastim injection to 336 hours based on CD-34 cells count (CD34) | Posted | Mean | Standard Deviation | cell per microliter / hour | 0 to 336 hours post-dose |
|
|
|
| Secondary | CD34-Emax | Maximal absolute count of CD34-cells after single filgrastim injection | Posted | Mean | Standard Deviation | cell per microliter | 0 to 336 hours post-dose |
|
|
|
| Secondary | Overall Frequency of Serious Adverse Events (SAE) | Posted | Count of Participants | Participants | 0 to 336 hours post-dose |
|
|
|
| Secondary | Overall Frequency of Adverse Events (AE) | Posted | Count of Participants | Participants | 0 to 336 hours post-dose |
|
|
|
| Secondary | Frequency of Local Reactions | Posted | Count of Participants | Participants | 0 to 336 hours post-dose |
|
|
|
| Secondary | Frequency of AE/SAE 3-4 Grade CTCAE 4.03 | Grading scale of CTCAE 4.03 Grade refers to the severity of the AE. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE: Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL (activities of daily living). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE. | Posted | Count of Participants | Participants | 0 to 336 hours post-dose |
|
|
|
| Secondary | Frequency of Preliminary Withdrawal Due to AE/SAE | Posted | Count of Participants | Participants | 0 to 336 hours post-dose |
|
|
|
| Secondary | Proportion of Patients With Binding or Neutralizing Antibodies to Filgrastim | Proportion of patients who had developed binding or neutralizing antibodies to filgrastim after single injection. | Posted | Count of Participants | Participants | 0 to 336 hours post-dose |
|
|
|
| 0 |
| 36 |
| 0 |
| 36 |
| 36 |
| 36 |
| EG001 | Neupogen® Subcutaneous Injections | Healthy volunteers in this group received single subcutaneous injection Neupogen®, on Day 1(in group Neupogen®-->Leucostim®) or single subcutaneous injection Neupogen® on Day 29 (in group Leucostim®-->Neupogen®) Leucostim®: Leucostim® is filgrastim biosimilar. Neupogen® | 0 | 36 | 0 | 36 | 35 | 36 |
| EG002 | Leucostim®, Intravenous Injections | Healthy volunteers in this group received single intravenous injection Leucostim® on Day 1(in group Leucostim®-->Neupogen®) or single subcutaneous injection Leucostim® on Day 29 (in group Neupogen® --> Leucostim®) Leucostim®: Leucostim® is filgrastim biosimilar. Neupogen® | 0 | 24 | 0 | 24 | 22 | 24 |
| EG003 | Neupogen®, Intravenous Injections | Healthy volunteers in this group received single intravenous injection Neupogen®, on Day 1(in group Neupogen®-->Leucostim®) or single subcutaneous injection Neupogen® on Day 29 (in group Leucostim®-->Neupogen®) Leucostim®: Leucostim® is filgrastim biosimilar. Neupogen® | 0 | 23 | 0 | 23 | 22 | 23 |
| head pain | Nervous system disorders | Non-systematic Assessment |
|
| Monocytosis | Blood and lymphatic system disorders | Systematic Assessment |
|
| eosinophilia | Blood and lymphatic system disorders | Systematic Assessment |
|
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| D013568 | Pathological Conditions, Signs and Symptoms |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| Male |
|