- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03103438
First-in-human Study of Safety, Pharmacokinetics and Pharmacodynamics of Various Doses of BCD-089 in Healthy Subjects
February 9, 2021 updated by: Biocad
An Open-Label, Dose Escalation Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Subcutaneous Dose of BCD-089 in Healthy Volunteers
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.
Study Overview
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
19
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Saint-Petersburg, Russian Federation
- LLC BioEk
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
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
- normal hemodynamic parameters :
- absence of chronic infections (HIV, syphilis, hepatitis В or С, tuberculosis ) and chronic inflammation
- absence of infections within 4 weeks before screening
- absence of mental disorders or other conditions, which may affect the ability of participant to follow Protocol
- absence of alcohol or drug addiction signs (incl. history of such addiction).
- 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 70 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-6 or IL-6R
- known severe allergy (anaphylaxis or multidrug intolerance)
- known intolerance to medicines containing monoclonal antibodies (murine, humanized, human) or to any excipients of BCD-089
- major surgery within 30 days prior screening
- severe infections (required hospitalization, parenteral use of antimicrobial agents) within 6 months prior the date of BCD-089 injection
- systemic use of antimicrobials within 2 months prior the date of BCD-089 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-089
- history of fever which was equal or exceeded 40 degrees in Celsius
- - actual or prior depression, suicidal tendencies
- use of any medicines, vitamins, biologically active additives within 14 days prior the screening examination use of any medicines which affects hemodynamics or hepatic function within 30 days prior the screening examination simultaneous participation in any other clinical trial, as well as former participation in other clinical trials within 2 months before this study initiation.
previous participation in this study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: FACTORIAL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: Cohort 1
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.
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Other Names:
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EXPERIMENTAL: Cohort 2
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.
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Other Names:
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EXPERIMENTAL: Cohort 3
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.
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Other Names:
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EXPERIMENTAL: Cohort 4
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.
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Other Names:
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EXPERIMENTAL: Cohort 5
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.
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Other Names:
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EXPERIMENTAL: Cohort 6
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.
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Other Names:
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EXPERIMENTAL: Cohort 7
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.
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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
Time Frame: 70 days
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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.
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70 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
November 1, 2016
Primary Completion (ACTUAL)
May 1, 2017
Study Completion (ACTUAL)
May 1, 2017
Study Registration Dates
First Submitted
March 24, 2017
First Submitted That Met QC Criteria
March 31, 2017
First Posted (ACTUAL)
April 6, 2017
Study Record Updates
Last Update Posted (ACTUAL)
February 26, 2021
Last Update Submitted That Met QC Criteria
February 9, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- BCD-089-1
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
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