Healthy
Conditions
Keywords
interleukin-17, maximum tolerated dose, novel monoclonal antibody
Brief summary
This is an open label, phase 1, 3+3 dose escalating study of tolerability, safety, pharmacokinetics and immunogenicity of a single subcutaneous injection of the novel monoclonal antibody against human IL-17 - BCD-085. The study will enroll 37 healthy male volunteers.
Detailed description
IL-17 is a new potential therapeutic target which plays important role in pathogenesis of several autoimmune disorders including psoriasis, rheumatoid arthritis, possibly - SLE and MS. BCD-085 is a novel humanized monoclonal antibody against human IL17 developed by JCS BIOCAD (Russia) which is now on the first step of clinical evaluation. BCD-085-1 study is the first-in-human clinical trial which is intended to evaluate tolerability, safety, pharmacokinetics and immunogenicity of BCD-085 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-085 (incl. MTD) which thereafter can be evaluated in phase 2 studies.
Interventions
DRUGhumanized monoclonal antibody against human IL-17
Sponsors
Biocad
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* singed informed consent * male gender * 18-45 years of age inclusively * BMI between18.5-30.0 kg/sq.m. * absence of any sings of hepatic, renal, gastrointestinal, cardiovascular, endocrine, respiratory, immunologic, hematologic, dermatologic, or neurologic abnormality at screening or/and in anamnesis * parameters of complete blood count, blood biochemistry, and urinalysis do not exceed reference values, which are used at Study site laboratory. Evaluation of required laboratory parameters must be performed within 14 days before randomization * normal hemodynamic parameters : systolic BP 100 - 139 mm Hg, diastolic BP - 60 - 90 mm Hg, heart rate - 60 - 90 b/min * absence of chronic infections (HIV, syphilis, hepatitis В or С, tuberculosis ) and chronic inflammation * absence of infections within 4 weeks before randomization * absence of mental disorders or other conditions (incl. depression), which may affect the ability of participant to follow Protocol * health well-being (by volunteer's opining opinion) for at least 30 days before randomization. * absence of alcohol or drug addiction signs (incl. history of such addiction). Consent not to use alcohol within 24 hours before and after injection of BCD-085; * volunteer's ability to follow Protocol procedures * consent of volunteers and their sexual partners with childbearing potential to use adequate contraception during screening period and the main study part (14 days before randomization and 61 day after SC injection). This requirement is not applicable in surgically sterilized volunteers. Adequate contraception includes the use of one barrier method in combination with spermicides, intrauterine device / oral contraceptives in sexual partner
Exclusion criteria
* history of use of monoclonal antibodies against IL-17 * known severe allergy (anaphylaxis or multidrug intolerance) * known intolerance to medicines containing monoclonal antibodies (murine, humanized, human) or to any excipients of BCD-085 * major surgery within 30 days prior screening * severe infections (required hospitalization, parenteral use of antimicrobial agents) within 6 months prior the date of BCD-085 injection * systemic use of antimicrobials within 2 months prior the date of BCD-085 injection * more than 4 episodes of respiratory tract infections within 6 months prior the screening examination * presence of any disorders which may affect pharmacokinetics of BCD-085 * history of fever which was equal or exceeded 40 degrees in Celsius * history of hepatic transaminases increase 2.5 x ULN * history of seizures * actual or prior depression, suicidal tendencies * use of any medicines, vitamins, biologically active additives within 14 days prior the date of BCD-085 injection * use of any medicines which affects hemodynamics or hepatic function within 30 days prior the date of BCD-085 injection * use of any medicines which may influence on immune system within 30 days prior the date of BCD-085 injection * vaccination within 4 weeks prior the date of BCD-085 injection * smoking exceeds 10 cigarettes per day * use of alcohol, which exceeds 10 units per week (1 alcohol unit is equal ½ l of beer (1 pint), or 200 ml of vine, or 50 ml alcohol * donation of more than 450 ml of blood or plasma within 2 months prior randomization. * simultaneous participation in any other clinical trial, as well as former participation in other clinical trials within 3 months before this study initiation. * previous participation in this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Plasma Concentration of BCD-085-time Curve From Zero (0) Hours to 1344 Hours After the Single Subcutaneous Injection of BCD-085 | 56 days | The blood sampling for the pharmacokinetic evaluations was performed at the following time points: 0 h (5 min before the injection) and at 0.5 hours, 2 hours, 4 hours, 8 hours, 12 hours, 24 hours, 48 hours, 72 hours,168 hours, 336 hours, 504 hours, 672 hours, 840 hours, 1008 hours, 1176 hours, and 1344 hours following the drug administration. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Concentration of BCD-085 After Single Subcutaneous Injection | 56 days | To assess the maximum observed concentration (Cmax) following single SC administer regardless of the cohort |
Other
| Measure | Time frame | Description |
|---|---|---|
| Constant of Elimination of BCD-085 After Single Subcutaneous Injection | 56 days | — |
| Clearance of BCD-085 After Single Subcutaneous Injection | 56 days | — |
| Mean Pain Score by VAS Assessment During Injection of BCD-085 | day 1 | The study subject assesses how painful was the injection. Assessment is performed by filling out a special 10-score visual analogue scale (VAS) immediately after the injection is done. The 0 score refers to no pain, the score 10 refers to the highest, almost unbearable pain. The pain was assessed after a single injection. |
| Total Frequency of AE/SAE | 56 days | — |
| Time of Maximum Concentration of BCD-085 After Single Subcutaneous Injection | 56 days | To assess the Tmax following single SC administer regardless of the cohort |
| Frequency of Grade 3-4 AEs | 56 days | — |
| Frequency of Early Discontinuation Due to AE | 56 days | — |
| Frequency of Binding Antibodies to BCD-85 Formation | day 56 | — |
| Frequency of Local Reactions | 56 days | — |
| Half-life of BCD-085 After Single Subcutaneous Injection | 56 days | — |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cohort no.1 This cohort includes just one subject who received the maximum safe starting dose of BCD-085 (0.05 mg/kg) subcutaneously. | 1 |
| Cohort no.2 This cohort includes 3 subjects who received the single subcutaneous injection of BCD-085 at a dose of 0.05 mg/kg. | 3 |
| Cohort no.3 This cohort includes 3 subjects who received the single subcutaneous injection of BCD-085 at a dose of 0.25 mg/kg. | 3 |
| Cohort no.4 This cohort includes 3 subjects who received the single subcutaneous injection of BCD-085 at a dose of 0.825 mg/kg. | 3 |
| Cohort no.5 This cohort includes 3 subjects who received the single subcutaneous injection of BCD-085 at a dose of 1.25 mg/kg. | 3 |
| Cohort no.6 This cohort includes 3 subjects who received the single subcutaneous injection of BCD-085 at a dose of 1.75 mg/kg. | 3 |
| Cohort no.7 This cohort includes 3 subjects who received the single subcutaneous injection of BCD-085 at a dose of 2.25 mg/kg. | 3 |
| Cohort no.8 This cohort includes 3 subjects who received the single subcutaneous injection of BCD-085 at a dose of 3.0 mg/kg. | 3 |
| Total | 22 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 |
|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Cohort no.1 | Cohort no.2 | Cohort no.3 | Cohort no.4 | Cohort no.5 | Cohort no.6 | Cohort no.7 | Cohort no.8 | Total |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 3 Participants | 3 Participants | 3 Participants | 3 Participants | 3 Participants | 3 Participants | 3 Participants | 22 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 1 Participants | 3 Participants | 3 Participants | 3 Participants | 3 Participants | 3 Participants | 3 Participants | 3 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 1 / 1 | 0 / 3 | 1 / 3 | 0 / 3 | 2 / 3 | 1 / 3 | 0 / 3 | 0 / 3 |
| serious Total, serious adverse events | 0 / 1 | 0 / 3 | 1 / 3 | 0 / 3 | 0 / 3 | 0 / 3 | 0 / 3 | 0 / 3 |
Outcome results
Primary
Area Under the Plasma Concentration of BCD-085-time Curve From Zero (0) Hours to 1344 Hours After the Single Subcutaneous Injection of BCD-085
The blood sampling for the pharmacokinetic evaluations was performed at the following time points: 0 h (5 min before the injection) and at 0.5 hours, 2 hours, 4 hours, 8 hours, 12 hours, 24 hours, 48 hours, 72 hours,168 hours, 336 hours, 504 hours, 672 hours, 840 hours, 1008 hours, 1176 hours, and 1344 hours following the drug administration.
Time frame: 56 days
Population: The analysis population includes all subjects for whom not more than 2 blood samples for BCD-085 assay were missing or unevaluable, and for whom no violations of blood sampling schedule were reported. Results of PK parameters consider in Cohort 1 and 2 together since the same dose were injected.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort 1 + Cohort 2 | Area Under the Plasma Concentration of BCD-085-time Curve From Zero (0) Hours to 1344 Hours After the Single Subcutaneous Injection of BCD-085 | 594222.00 (ng/ml)*hour |
| Cohort 3 | Area Under the Plasma Concentration of BCD-085-time Curve From Zero (0) Hours to 1344 Hours After the Single Subcutaneous Injection of BCD-085 | 2262670.25 (ng/ml)*hour |
| Cohort 4 | Area Under the Plasma Concentration of BCD-085-time Curve From Zero (0) Hours to 1344 Hours After the Single Subcutaneous Injection of BCD-085 | 5669903.75 (ng/ml)*hour |
| Cohort 5 | Area Under the Plasma Concentration of BCD-085-time Curve From Zero (0) Hours to 1344 Hours After the Single Subcutaneous Injection of BCD-085 | 9939951.75 (ng/ml)*hour |
| Cohort 6 | Area Under the Plasma Concentration of BCD-085-time Curve From Zero (0) Hours to 1344 Hours After the Single Subcutaneous Injection of BCD-085 | 9220825.00 (ng/ml)*hour |
| Cohort 7 | Area Under the Plasma Concentration of BCD-085-time Curve From Zero (0) Hours to 1344 Hours After the Single Subcutaneous Injection of BCD-085 | 14915081.50 (ng/ml)*hour |
| Cohort 8 | Area Under the Plasma Concentration of BCD-085-time Curve From Zero (0) Hours to 1344 Hours After the Single Subcutaneous Injection of BCD-085 | 10152522550.50 (ng/ml)*hour |
Secondary
Maximum Concentration of BCD-085 After Single Subcutaneous Injection
To assess the maximum observed concentration (Cmax) following single SC administer regardless of the cohort
Time frame: 56 days
Population: The analysis population includes all subjects for whom not more than 2 blood samples for BCD-085 assay were missing or unevaluable, and for whom no violations of blood sampling schedule were reported. Results of PK parameters consider in Cohort 1 and 2 together since the same dose were injected.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1 + Cohort 2 | Maximum Concentration of BCD-085 After Single Subcutaneous Injection | 583.5 ng/mL | Standard Deviation 53.3 |
| Cohort 3 | Maximum Concentration of BCD-085 After Single Subcutaneous Injection | 2566.00 ng/mL | Standard Deviation 504.87 |
| Cohort 4 | Maximum Concentration of BCD-085 After Single Subcutaneous Injection | 8970.67 ng/mL | Standard Deviation 1831.26 |
| Cohort 5 | Maximum Concentration of BCD-085 After Single Subcutaneous Injection | 12946.67 ng/mL | Standard Deviation 1744.52 |
| Cohort 6 | Maximum Concentration of BCD-085 After Single Subcutaneous Injection | 12415.33 ng/mL | Standard Deviation 4280.65 |
| Cohort 7 | Maximum Concentration of BCD-085 After Single Subcutaneous Injection | 20115.00 ng/mL | Standard Deviation 1413.55 |
| Cohort 8 | Maximum Concentration of BCD-085 After Single Subcutaneous Injection | 28691.33 ng/mL | Standard Deviation 1478 |
Other Pre-specified
Clearance of BCD-085 After Single Subcutaneous Injection
Time frame: 56 days
Population: The analysis population includes all subjects for whom not more than 2 blood samples for BCD-085 assay were missing or unevaluable, and for whom no violations of blood sampling schedule were reported. Results of PK parameters consider in Cohort 1 and 2 together since the same dose were injected.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1 + Cohort 2 | Clearance of BCD-085 After Single Subcutaneous Injection | 6.18 mL/h | Standard Deviation 2.16 |
| Cohort 3 | Clearance of BCD-085 After Single Subcutaneous Injection | 10.25 mL/h | Standard Deviation 1.81 |
| Cohort 4 | Clearance of BCD-085 After Single Subcutaneous Injection | 8.80 mL/h | Standard Deviation 1.04 |
| Cohort 5 | Clearance of BCD-085 After Single Subcutaneous Injection | 8.75 mL/h | Standard Deviation 2.63 |
| Cohort 6 | Clearance of BCD-085 After Single Subcutaneous Injection | 16.05 mL/h | Standard Deviation 2.36 |
| Cohort 7 | Clearance of BCD-085 After Single Subcutaneous Injection | 12.29 mL/h | Standard Deviation 1.43 |
| Cohort 8 | Clearance of BCD-085 After Single Subcutaneous Injection | 11.45 mL/h | Standard Deviation 1.81 |
Other Pre-specified
Constant of Elimination of BCD-085 After Single Subcutaneous Injection
Time frame: 56 days
Population: The analysis population includes all subjects for whom not more than 2 blood samples for BCD-085 assay were missing or unevaluable, and for whom no violations of blood sampling schedule were reported. Results of PK parameters consider in Cohort 1 and 2 together since the same dose were injected.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1 + Cohort 2 | Constant of Elimination of BCD-085 After Single Subcutaneous Injection | 0.002 hours^-1 | Standard Deviation 0 |
| Cohort 3 | Constant of Elimination of BCD-085 After Single Subcutaneous Injection | 0.002 hours^-1 | Standard Deviation 0 |
| Cohort 4 | Constant of Elimination of BCD-085 After Single Subcutaneous Injection | 0.002 hours^-1 | Standard Deviation 0 |
| Cohort 5 | Constant of Elimination of BCD-085 After Single Subcutaneous Injection | 0.002 hours^-1 | Standard Deviation 0 |
| Cohort 6 | Constant of Elimination of BCD-085 After Single Subcutaneous Injection | 0.002 hours^-1 | Standard Deviation 0 |
| Cohort 7 | Constant of Elimination of BCD-085 After Single Subcutaneous Injection | 0.002 hours^-1 | Standard Deviation 0 |
| Cohort 8 | Constant of Elimination of BCD-085 After Single Subcutaneous Injection | 0.002 hours^-1 | Standard Deviation 0 |
Other Pre-specified
Frequency of Binding Antibodies to BCD-85 Formation
Time frame: day 56
Population: Immunogenicity was evaluated in all volunteers who received the drug administration, and who had both samples, available for analysis. Volunteer from Cohort 3 had early withdrawal, so he did not have a second sample for the study. Thus, the total number of volunteers for immunogenicity assessment was 21.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1 + Cohort 2 | Frequency of Binding Antibodies to BCD-85 Formation | 0 Participants |
| Cohort 3 | Frequency of Binding Antibodies to BCD-85 Formation | 0 Participants |
| Cohort 4 | Frequency of Binding Antibodies to BCD-85 Formation | 0 Participants |
| Cohort 5 | Frequency of Binding Antibodies to BCD-85 Formation | 0 Participants |
| Cohort 6 | Frequency of Binding Antibodies to BCD-85 Formation | 0 Participants |
| Cohort 7 | Frequency of Binding Antibodies to BCD-85 Formation | 0 Participants |
| Cohort 8 | Frequency of Binding Antibodies to BCD-85 Formation | 0 Participants |
| Cohort 8 | Frequency of Binding Antibodies to BCD-85 Formation | 0 Participants |
Other Pre-specified
Frequency of Early Discontinuation Due to AE
Time frame: 56 days
Population: The safety population included all subjects who received at least one injection of the study drug
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1 + Cohort 2 | Frequency of Early Discontinuation Due to AE | 0 Participants |
| Cohort 3 | Frequency of Early Discontinuation Due to AE | 0 Participants |
| Cohort 4 | Frequency of Early Discontinuation Due to AE | 1 Participants |
| Cohort 5 | Frequency of Early Discontinuation Due to AE | 0 Participants |
| Cohort 6 | Frequency of Early Discontinuation Due to AE | 0 Participants |
| Cohort 7 | Frequency of Early Discontinuation Due to AE | 0 Participants |
| Cohort 8 | Frequency of Early Discontinuation Due to AE | 0 Participants |
| Cohort 8 | Frequency of Early Discontinuation Due to AE | 0 Participants |
Other Pre-specified
Frequency of Grade 3-4 AEs
Time frame: 56 days
Population: The safety population included all subjects who received at least one injection of the study drug
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1 + Cohort 2 | Frequency of Grade 3-4 AEs | 0 Participants |
| Cohort 3 | Frequency of Grade 3-4 AEs | 0 Participants |
| Cohort 4 | Frequency of Grade 3-4 AEs | 1 Participants |
| Cohort 5 | Frequency of Grade 3-4 AEs | 0 Participants |
| Cohort 6 | Frequency of Grade 3-4 AEs | 0 Participants |
| Cohort 7 | Frequency of Grade 3-4 AEs | 0 Participants |
| Cohort 8 | Frequency of Grade 3-4 AEs | 0 Participants |
| Cohort 8 | Frequency of Grade 3-4 AEs | 0 Participants |
Other Pre-specified
Frequency of Local Reactions
Time frame: 56 days
Population: Safety population included all subjects who received at least one injection of the study drug
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1 + Cohort 2 | Frequency of Local Reactions | 0 Participants |
| Cohort 3 | Frequency of Local Reactions | 0 Participants |
| Cohort 4 | Frequency of Local Reactions | 0 Participants |
| Cohort 5 | Frequency of Local Reactions | 0 Participants |
| Cohort 6 | Frequency of Local Reactions | 0 Participants |
| Cohort 7 | Frequency of Local Reactions | 0 Participants |
| Cohort 8 | Frequency of Local Reactions | 0 Participants |
| Cohort 8 | Frequency of Local Reactions | 0 Participants |
Other Pre-specified
Half-life of BCD-085 After Single Subcutaneous Injection
Time frame: 56 days
Population: The analysis population includes all subjects for whom not more than 2 blood samples for BCD-085 assay were missing or unevaluable, and for whom no violations of blood sampling schedule were reported. Results of PK parameters consider in Cohort 1 and 2 together since the same dose were injected.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort 1 + Cohort 2 | Half-life of BCD-085 After Single Subcutaneous Injection | 425.15 hours |
| Cohort 3 | Half-life of BCD-085 After Single Subcutaneous Injection | 378.78 hours |
| Cohort 4 | Half-life of BCD-085 After Single Subcutaneous Injection | 370.13 hours |
| Cohort 5 | Half-life of BCD-085 After Single Subcutaneous Injection | 362.78 hours |
| Cohort 6 | Half-life of BCD-085 After Single Subcutaneous Injection | 428.42 hours |
| Cohort 7 | Half-life of BCD-085 After Single Subcutaneous Injection | 370.70 hours |
| Cohort 8 | Half-life of BCD-085 After Single Subcutaneous Injection | 375.76 hours |
Other Pre-specified
Mean Pain Score by VAS Assessment During Injection of BCD-085
The study subject assesses how painful was the injection. Assessment is performed by filling out a special 10-score visual analogue scale (VAS) immediately after the injection is done. The 0 score refers to no pain, the score 10 refers to the highest, almost unbearable pain. The pain was assessed after a single injection.
Time frame: day 1
Population: The safety analysis will include all subjects received BCD-085.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1 + Cohort 2 | Mean Pain Score by VAS Assessment During Injection of BCD-085 | 0 score on a scale | Standard Deviation 0 |
| Cohort 3 | Mean Pain Score by VAS Assessment During Injection of BCD-085 | 0 score on a scale | Standard Deviation 0 |
| Cohort 4 | Mean Pain Score by VAS Assessment During Injection of BCD-085 | 0 score on a scale | Standard Deviation 0 |
| Cohort 5 | Mean Pain Score by VAS Assessment During Injection of BCD-085 | 0 score on a scale | Standard Deviation 0 |
| Cohort 6 | Mean Pain Score by VAS Assessment During Injection of BCD-085 | 0 score on a scale | Standard Deviation 0 |
| Cohort 7 | Mean Pain Score by VAS Assessment During Injection of BCD-085 | 0 score on a scale | Standard Deviation 0 |
| Cohort 8 | Mean Pain Score by VAS Assessment During Injection of BCD-085 | 0 score on a scale | Standard Deviation 0 |
| Cohort 8 | Mean Pain Score by VAS Assessment During Injection of BCD-085 | 0 score on a scale | Standard Deviation 0 |
Other Pre-specified
Time of Maximum Concentration of BCD-085 After Single Subcutaneous Injection
To assess the Tmax following single SC administer regardless of the cohort
Time frame: 56 days
Population: The analysis population includes all subjects for whom not more than 2 blood samples for BCD-085 assay were missing or unevaluable, and for whom no violations of blood sampling schedule were reported. Results of PK parameters consider in Cohort 1 and 2 together since the same dose were injected.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort 1 + Cohort 2 | Time of Maximum Concentration of BCD-085 After Single Subcutaneous Injection | 252.000 hours |
| Cohort 3 | Time of Maximum Concentration of BCD-085 After Single Subcutaneous Injection | 168.000 hours |
| Cohort 4 | Time of Maximum Concentration of BCD-085 After Single Subcutaneous Injection | 168.000 hours |
| Cohort 5 | Time of Maximum Concentration of BCD-085 After Single Subcutaneous Injection | 72.000 hours |
| Cohort 6 | Time of Maximum Concentration of BCD-085 After Single Subcutaneous Injection | 48.000 hours |
| Cohort 7 | Time of Maximum Concentration of BCD-085 After Single Subcutaneous Injection | 168.000 hours |
| Cohort 8 | Time of Maximum Concentration of BCD-085 After Single Subcutaneous Injection | 168.000 hours |
Other Pre-specified
Total Frequency of AE/SAE
Time frame: 56 days
Population: The analysis population includes subjects who received any dose of BCD-085 subcutaneously.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1 + Cohort 2 | Total Frequency of AE/SAE | Total frequency of SAEs | 0 Participants |
| Cohort 1 + Cohort 2 | Total Frequency of AE/SAE | Total frequency of AEs | 1 Participants |
| Cohort 3 | Total Frequency of AE/SAE | Total frequency of AEs | 0 Participants |
| Cohort 3 | Total Frequency of AE/SAE | Total frequency of SAEs | 0 Participants |
| Cohort 4 | Total Frequency of AE/SAE | Total frequency of AEs | 1 Participants |
| Cohort 4 | Total Frequency of AE/SAE | Total frequency of SAEs | 1 Participants |
| Cohort 5 | Total Frequency of AE/SAE | Total frequency of AEs | 0 Participants |
| Cohort 5 | Total Frequency of AE/SAE | Total frequency of SAEs | 0 Participants |
| Cohort 6 | Total Frequency of AE/SAE | Total frequency of SAEs | 0 Participants |
| Cohort 6 | Total Frequency of AE/SAE | Total frequency of AEs | 2 Participants |
| Cohort 7 | Total Frequency of AE/SAE | Total frequency of AEs | 1 Participants |
| Cohort 7 | Total Frequency of AE/SAE | Total frequency of SAEs | 0 Participants |
| Cohort 8 | Total Frequency of AE/SAE | Total frequency of AEs | 0 Participants |
| Cohort 8 | Total Frequency of AE/SAE | Total frequency of SAEs | 0 Participants |
| Cohort 8 | Total Frequency of AE/SAE | Total frequency of AEs | 0 Participants |
| Cohort 8 | Total Frequency of AE/SAE | Total frequency of SAEs | 0 Participants |