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First-in-human Study to Evaluate Safety, Tolerability and Pharmacokinetics of Various Doses of BCD-085 in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT02380287
Recruitment Status : Completed
First Posted : March 5, 2015
Results First Posted : May 23, 2016
Last Update Posted : May 23, 2016
Sponsor:
Information provided by (Responsible Party):
Biocad

Tracking Information
First Submitted Date  ICMJE March 2, 2015
First Posted Date  ICMJE March 5, 2015
Results First Submitted Date  ICMJE March 31, 2016
Results First Posted Date  ICMJE May 23, 2016
Last Update Posted Date May 23, 2016
Study Start Date  ICMJE March 2015
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 4, 2015)
Area Under the Plasma Concentration of BCD-085-time Curve From Zero (0) Hours to 1320 Hours After the Single Subcutaneous Injection of BCD-085 [ Time Frame: 57 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 4, 2015)
Maximum Concentration of BCD-085 After Single Subcutaneous Injection [ Time Frame: 57 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: March 4, 2015)
  • Time of Maximum Concentration of BCD-085 After Single Subcutaneous Injection [ Time Frame: 57 days ]
  • Half-life of BCD-085 After Single Subcutaneous Injection [ Time Frame: 57 days ]
  • Constant of Elimination of BCD-085 After Single Subcutaneous Injection [ Time Frame: 57 days ]
  • Clearance of BCD-085 After Single Subcutaneous Injection [ Time Frame: 57 days ]
  • Mean Pain Score by VAS Assessment During Injection of BCD-085 [ Time Frame: day 1 ]
  • Total Frequency of AE/SAE [ Time Frame: 57 days ]
  • Frequency of Local Reactions [ Time Frame: 57 days ]
  • Frequency of Grade 3-4 AEs [ Time Frame: 57 days ]
  • Frequency of Early Discontinuation Due to AE [ Time Frame: 57 days ]
  • Frequency of Binding Antibodies to BCD-85 Formation [ Time Frame: day 57 ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE First-in-human Study to Evaluate Safety, Tolerability and Pharmacokinetics of Various Doses of BCD-085 in Healthy Subjects
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE Drug: humanized monoclonal antibody against human IL-17
Other Name: BCD-085
Study Arms  ICMJE
  • 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.
    Intervention: Drug: humanized monoclonal antibody against human IL-17
  • 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.

    Intervention: Drug: humanized monoclonal antibody against human IL-17
  • 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.

    Intervention: Drug: humanized monoclonal antibody against human IL-17
  • 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.

    Intervention: Drug: humanized monoclonal antibody against human IL-17
  • 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.

    Intervention: Drug: humanized monoclonal antibody against human IL-17
  • 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.

    Intervention: Drug: humanized monoclonal antibody against human IL-17
  • 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.

    Intervention: Drug: humanized monoclonal antibody against human IL-17
  • 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.

    Intervention: Drug: humanized monoclonal antibody against human IL-17
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 12, 2016)
22
Original Estimated Enrollment  ICMJE
 (submitted: March 4, 2015)
37
Actual Study Completion Date  ICMJE October 2015
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02380287
Other Study ID Numbers  ICMJE BCD-085-1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Biocad
Study Sponsor  ICMJE Biocad
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Roman Ivanov, PhD JCS BIOCAD
PRS Account Biocad
Verification Date April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP