- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02380287
First-in-human Study to Evaluate Safety, Tolerability and Pharmacokinetics of Various Doses of BCD-085 in Healthy Subjects
Open-label, Phase I Dose-escalation Clinical Study of the Safety, Tolerability and Pharmacokinetics of Single Subcutaneus Dose of BCD-085, Monoclonal Antibody Against IL-17, in Healthy Subjects
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 1
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cohort no.1
This cohort includes just one subject who will receive the maximum safe starting dose of BCD-085 (0.05 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.
|
Other Names:
|
Experimental: Cohort no.2
This cohort includes 3 subjects who will receive the single subcutaneous injection of BCD-085 at a dose of 0.05 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. |
Other Names:
|
Experimental: Cohort no.3
This cohort includes 3 subjects who will receive the single subcutaneous injection of BCD-085 at a dose of 0.25 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. |
Other Names:
|
Experimental: Cohort no.4
This cohort includes 3 subjects who will receive the single subcutaneous injection of BCD-085 at a dose of 0.825 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. |
Other Names:
|
Experimental: Cohort no.5
This cohort includes 3 subjects who will receive the single subcutaneous injection of BCD-085 at a dose of 1.25 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. |
Other Names:
|
Experimental: Cohort no.6
This cohort includes 3 subjects who will receive the single subcutaneous injection of BCD-085 at a dose of 1.75 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. |
Other Names:
|
Experimental: Cohort no.7
This cohort includes 3 subjects who will receive the single subcutaneous injection of BCD-085 at a dose of 2.25 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. 8 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. 8. |
Other Names:
|
Experimental: Cohort no.8
This cohort includes 3 subjects who will receive the single subcutaneous injection of BCD-085 at a dose of 3.0 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 exactly 1 of the 3 subjects treated show DLT, 3 additional subjects are treated at the current dose level. |
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
Time Frame: 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.
|
56 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum Concentration of BCD-085 After Single Subcutaneous Injection
Time Frame: 56 days
|
To assess the maximum observed concentration (Cmax) following single SC administer regardless of the cohort
|
56 days
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time of Maximum Concentration of BCD-085 After Single Subcutaneous Injection
Time Frame: 56 days
|
To assess the Tmax following single SC administer regardless of the cohort
|
56 days
|
Half-life of BCD-085 After Single Subcutaneous Injection
Time Frame: 56 days
|
56 days
|
|
Constant of Elimination of BCD-085 After Single Subcutaneous Injection
Time Frame: 56 days
|
56 days
|
|
Clearance of BCD-085 After Single Subcutaneous Injection
Time Frame: 56 days
|
56 days
|
|
Mean Pain Score by VAS Assessment During Injection of BCD-085
Time Frame: 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.
|
day 1
|
Total Frequency of AE/SAE
Time Frame: 56 days
|
56 days
|
|
Frequency of Local Reactions
Time Frame: 56 days
|
56 days
|
|
Frequency of Grade 3-4 AEs
Time Frame: 56 days
|
56 days
|
|
Frequency of Early Discontinuation Due to AE
Time Frame: 56 days
|
56 days
|
|
Frequency of Binding Antibodies to BCD-85 Formation
Time Frame: day 56
|
day 56
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BCD-085-1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy
-
Prevent Age Resort "Pervaya Liniya"RecruitingHealthy Aging | Healthy Diet | Healthy LifestyleRussian Federation
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
Yale UniversityNot yet recruitingHealth-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For HealthHealthy Diet | Healthy Lifestyle | Healthy Nutrition | CholesterolUnited States
-
Hasselt UniversityRecruitingHealthy | Healthy AgingBelgium
-
Galera Therapeutics, Inc.Syneos HealthCompleted
-
Galera Therapeutics, Inc.Syneos HealthCompletedHealthy | Healthy VolunteersAustralia
-
University of PennsylvaniaActive, not recruitingHealthy | Healthy AgingUnited States
-
Chalmers University of TechnologyGöteborg UniversityCompletedHealthy | Nutrition, HealthySweden
-
University of ManitobaNot yet recruitingHealthy | Healthy Diet
Clinical Trials on humanized monoclonal antibody against human IL-17
-
Shanghai Junshi Bioscience Co., Ltd.RecruitingModerate to Severe Chronic Plaque PsoriasisChina
-
Bio-Thera SolutionsActive, not recruitingPlaque PsoriasisChina
-
Shanghai Junshi Bioscience Co., Ltd.UnknownTolerability, Safety, Immunogenicity and Pharmacokinetic of JS005China
-
BiocadCompleted
-
Shanghai Junshi Bioscience Co., Ltd.CompletedModerate to Severe PsoriasisChina
-
Bio-Thera SolutionsTerminated
-
AbbVie (prior sponsor, Abbott)CompletedMultiple SclerosisUnited States, Canada, Germany, Netherlands, United Kingdom
-
Shanghai Huaota Biopharmaceutical Co., Ltd.RecruitingGeneralized Pustular Psoriasis (GPP)China
-
Shanghai Junshi Bioscience Co., Ltd.Sponsor GmbHRecruitingActive Ankylosing SpondylitisChina