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This is an open label, phase 1, "3+3" dose escalating study of tolerability, safety, pharmacokinetics, pharmacodynamics and immunogenicity of a single subcutaneous injection of the novel monoclonal antibody against the interleukin-6 receptor - BCD-089. The study will enroll 19 healthy male volunteers.
IL-6 is a new potential therapeutic target which plays important role in pathogenesis of several autoimmune disorders including rheumatoid arthritis. BCD-089 is a novel fully human monoclonal antibody against the interleukin-6 receptor developed by JCS BIOCAD (Russia) which is now on the first step of clinical evaluation. BCD-089-1 study is the first-in-human clinical trial which is intended to evaluate tolerability, safety, pharmacokinetics, pharmacodynamics and immunogenicity of BCD-089 when used as a single step-by-step escalating subcutaneous dose in healthy male volunteers. During this study it is expected to determine diapason of safety doses of BCD-089 (incl. MTD) which thereafter can be evaluated in phase 2 studies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | his cohort includes one subject who will receive the maximum safe starting dose of BCD-089 (0.06 mg/kg) subcutaneously. If the dose limitating toxicity occurs within the first seven days after injection the study will be stopped. If there is no DLT within mentioned above period then Cohort no.2 is included. |
|
| Cohort 2 | Experimental | This cohort includes 3 subjects who will receive the single subcutaneous injection of BCD-089 at a dose of 0.3 mg/kg.If at least 2 subjects are observed to have DLT, this dose level is defined as the MTD (unless only 3 patients have been treated at that level, in which case it is the tentative MTD). If 0 of the 3 subjects are observed to have DLT, the dose level is escalated one step for the next cohort no.3 of 3 subjects, and the process continues as above. If exactly 1 of the 3 subjects treated show DLT, 3 additional subjects are treated at the current dose level. If none of these additional 3 patients show DLT, the dose level is escalated for the next Cohort no. 3. |
|
| Cohort 3 | Experimental | This cohort includes 3 subjects who will receive the single subcutaneous injection of BCD-089 at a dose of 0.625 mg/kg.If at least 2 subjects are observed to have DLT, this dose level is defined as the MTD (unless only 3 patients have been treated at that level, in which case it is the tentative MTD). If 0 of the 3 subjects are observed to have DLT, the dose level is escalated one step for the next cohort no. 4 of 3 subjects, and the process continues as above. If exactly 1 of the 3 subjects treated show DLT, 3 additional subjects are treated at the current dose level. If none of these additional 3 patients show DLT, the dose level is escalated for the next Cohort no. 4. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BCD-089 | Biological |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Plasma Concentration of BCD-089-time Curve From Zero (0) Hours to 1680 Hours After the Single Subcutaneous Injection of BCD-089 | Area Under the Plasma Concentration of BCD-089-time Curve From Zero (0) Hours to 1680 Hours After the Single Subcutaneous Injection of BCD-089. | 70 days |
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Inclusion Criteria:
Exclusion Criteria:
previous participation in this study
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LLC BioEk | Saint Petersburg | Russia |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1 | One subject received the maximum safe starting dose of BCD-089 (0.06 mg/kg) subcutaneously. |
| FG001 | Cohort 2 | Three subjects received the single subcutaneous injection of BCD-089 at a dose of 0.3 mg/kg. |
| FG002 | Cohort 3 | Three subjects received the single subcutaneous injection of BCD-089 at a dose of 0.625 mg/kg. |
| FG003 | Cohort 4 | Three subjects received the single subcutaneous injection of BCD-089 at a dose of 1.0 mg/kg. |
| FG004 | Cohort 5 | Three subjects received the single subcutaneous injection of BCD-089 at a dose of 1.6 mg/kg. |
| FG005 | Cohort 6 | Three subjects received the single subcutaneous injection of BCD-089 at a dose of 2.2 mg/kg. |
| FG006 | Cohort 7 | Three subjects received the single subcutaneous injection of BCD-089 at a dose of 2.9 mg/kg. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1 | One subject received the maximum safe starting dose of BCD-089 (0.06 mg/kg) subcutaneously. |
| BG001 | Cohort 2 | Three subjects received the single subcutaneous injection of BCD-089 at a dose of 0.3 mg/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 | Area Under the Plasma Concentration of BCD-089-time Curve From Zero (0) Hours to 1680 Hours After the Single Subcutaneous Injection of BCD-089 | Area Under the Plasma Concentration of BCD-089-time Curve From Zero (0) Hours to 1680 Hours After the Single Subcutaneous Injection of BCD-089. | The pharmacokinetic analysis population included the data from all volunteers included in the study (n = 19). | Posted | Median | Inter-Quartile Range | ng/ml*h | 70 days |
|
71 days from the moment of injection
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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 | Cohort 1 | One subject received the maximum safe starting dose of BCD-089 (0.06 mg/kg) subcutaneously. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| AST decreased | Hepatobiliary disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nadezhda Kravtsova | Biocad | +7 (812) 380 49 33 | kravtsovana@biocad.ru |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 1, 2016 | Feb 9, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| C000711672 | levilimab |
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| Cohort 4 | Experimental | This cohort includes 3 subjects who will receive the single subcutaneous injection of BCD-089 at a dose of 1.0 mg/kg. If at least 2 subjects are observed to have DLT, this dose level is defined as the MTD (unless only 3 patients have been treated at that level, in which case it is the tentative MTD). If 0 of the 3 subjects are observed to have DLT, the dose level is escalated one step for the next cohort no. 5 of 3 subjects, and the process continues as above. If exactly 1 of the 3 subjects treated show DLT, 3 additional subjects are treated at the current dose level. If none of these additional 3 patients show DLT, the dose level is escalated for the next Cohort no. 5. |
|
| Cohort 5 | Experimental | This cohort includes 3 subjects who will receive the single subcutaneous injection of BCD-089 at a dose of 1.6 mg/kg. If at least 2 subjects are observed to have DLT, this dose level is defined as the MTD (unless only 3 patients have been treated at that level, in which case it is the tentative MTD). If 0 of the 3 subjects are observed to have DLT, the dose level is escalated one step for the next cohort no. 6 of 3 subjects, and the process continues as above. If exactly 1 of the 3 subjects treated show DLT, 3 additional subjects are treated at the current dose level. If none of these additional 3 patients show DLT, the dose level is escalated for the next Cohort no. 6. |
|
| Cohort 6 | Experimental | This cohort includes 3 subjects who will receive the single subcutaneous injection of BCD-089 at a dose of 2.2 mg/kg. If at least 2 subjects are observed to have DLT, this dose level is defined as the MTD (unless only 3 patients have been treated at that level, in which case it is the tentative MTD). If 0 of the 3 subjects are observed to have DLT, the dose level is escalated one step for the next cohort no. 7 of 3 subjects, and the process continues as above. If exactly 1 of the 3 subjects treated show DLT, 3 additional subjects are treated at the current dose level. If none of these additional 3 patients show DLT, the dose level is escalated for the next Cohort no. 7. |
|
| Cohort 7 | Experimental | This cohort includes 3 subjects who will receive the single subcutaneous injection of BCD-089 at a dose of 2.9 mg/kg. If at least 2 subjects are observed to have DLT, this dose level is defined as the MTD (unless only 3 patients have been treated at that level, in which case it is the tentative MTD). If exactly 1 of the 3 subjects treated show DLT, 3 additional subjects are treated at the current dose level. |
|
| BG002 | Cohort 3 | Three subjects received the single subcutaneous injection of BCD-089 at a dose of 0.625 mg/kg. |
| BG003 | Cohort 4 | Three subjects received the single subcutaneous injection of BCD-089 at a dose of 1.0 mg/kg. |
| BG004 | Cohort 5 | Three subjects received the single subcutaneous injection of BCD-089 at a dose of 1.6 mg/kg. |
| BG005 | Cohort 6 | Three subjects received the single subcutaneous injection of BCD-089 at a dose of 2.2 mg/kg. |
| BG006 | Cohort 7 | Three subjects received the single subcutaneous injection of BCD-089 at a dose of 2.9 mg/kg. |
| BG007 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Cohort 3 | Three subjects received the single subcutaneous injection of BCD-089 at a dose of 0.625 mg/kg. |
| OG003 | Cohort 4 | Three subjects received the single subcutaneous injection of BCD-089 at a dose of 1.0 mg/kg. |
| OG004 | Cohort 5 | Three subjects received the single subcutaneous injection of BCD-089 at a dose of 1.6 mg/kg. |
| OG005 | Cohort 6 | Three subjects received the single subcutaneous injection of BCD-089 at a dose of 2.2 mg/kg. |
| OG006 | Cohort 7 | Three subjects received the single subcutaneous injection of BCD-089 at a dose of 2.9 mg/kg. |
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| 0 |
| 1 |
| 0 |
| 1 |
| 0 |
| 1 |
| EG001 | Cohort 2 | Three subjects received the single subcutaneous injection of BCD-089 at a dose of 0.3 mg/kg. | 0 | 3 | 0 | 3 | 1 | 3 |
| EG002 | Cohort 3 | Three subjects received the single subcutaneous injection of BCD-089 at a dose of 0.625 mg/kg. | 0 | 3 | 0 | 3 | 1 | 3 |
| EG003 | Cohort 4 | Three subjects received the single subcutaneous injection of BCD-089 at a dose of 1.0 mg/kg. | 0 | 3 | 0 | 3 | 1 | 3 |
| EG004 | Cohort 5 | Three subjects received the single subcutaneous injection of BCD-089 at a dose of 1.6 mg/kg. | 0 | 3 | 0 | 3 | 0 | 3 |
| EG005 | Cohort 6 | Three subjects received the single subcutaneous injection of BCD-089 at a dose of 2.2 mg/kg. | 0 | 3 | 0 | 3 | 2 | 3 |
| EG006 | Cohort 7 | Three subjects received the single subcutaneous injection of BCD-089 at a dose of 2.9 mg/kg. | 0 | 3 | 0 | 3 | 1 | 3 |
| total bilirubin increased | Hepatobiliary disorders | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
|
| creatinine decreased | Renal and urinary disorders | Systematic Assessment |
|
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