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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Factorial Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Healthy
Intervention Drug: humanized monoclonal antibody against human IL-17
Enrollment 22
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cohort no.1 Cohort no.2 Cohort no.3 Cohort no.4 Cohort no.5 Cohort no.6 Cohort no.7 Cohort no.8
Hide Arm/Group Description

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.

humanized monoclonal antibody against human IL-17

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.

humanized monoclonal antibody against human IL-17

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.

humanized monoclonal antibody against human IL-17

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.

humanized monoclonal antibody against human IL-17

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.

humanized monoclonal antibody against human IL-17

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.

humanized monoclonal antibody against human IL-17

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.

humanized monoclonal antibody against human IL-17

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.

humanized monoclonal antibody against human IL-17

Period Title: Overall Study
Started 1 3 3 3 3 3 3 3
Completed 1 3 2 3 3 3 3 3
Not Completed 0 0 1 0 0 0 0 0
Reason Not Completed
Adverse Event             0             0             1             0             0             0             0             0
Arm/Group Title 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
Hide Arm/Group Description This cohort includes just one subject who received the maximum safe starting dose of BCD-085 (0.05 mg/kg) subcutaneously. This cohort includes 3 subjects who received the single subcutaneous injection of BCD-085 at a dose of 0.05 mg/kg. This cohort includes 3 subjects who received the single subcutaneous injection of BCD-085 at a dose of 0.25 mg/kg. This cohort includes 3 subjects who received the single subcutaneous injection of BCD-085 at a dose of 0.825 mg/kg. This cohort includes 3 subjects who received the single subcutaneous injection of BCD-085 at a dose of 1.25 mg/kg. This cohort includes 3 subjects who received the single subcutaneous injection of BCD-085 at a dose of 1.75 mg/kg. This cohort includes 3 subjects who received the single subcutaneous injection of BCD-085 at a dose of 2.25 mg/kg. This cohort includes 3 subjects who received the single subcutaneous injection of BCD-085 at a dose of 3.0 mg/kg. Total of all reporting groups
Overall Number of Baseline Participants 1 3 3 3 3 3 3 3 22
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 3 participants 3 participants 3 participants 3 participants 3 participants 3 participants 3 participants 22 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
1
 100.0%
3
 100.0%
3
 100.0%
3
 100.0%
3
 100.0%
3
 100.0%
3
 100.0%
3
 100.0%
22
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 3 participants 3 participants 3 participants 3 participants 3 participants 3 participants 3 participants 22 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Male
1
 100.0%
3
 100.0%
3
 100.0%
3
 100.0%
3
 100.0%
3
 100.0%
3
 100.0%
3
 100.0%
22
 100.0%
1.Primary Outcome
Title 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
Hide Description [Not Specified]
Time Frame 57 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title BCD-085
Hide Arm/Group Description:
This cohort includes subjects who received any dose of BCD-085 subcutaneously.
Overall Number of Participants Analyzed 21
Median (Inter-Quartile Range)
Unit of Measure: (ng/ml)*hour
8169096
(2924632 to 13047991)
2.Secondary Outcome
Title Maximum Concentration of BCD-085 After Single Subcutaneous Injection
Hide Description [Not Specified]
Time Frame 57 days
Outcome Measure Data Not Reported
3.Other Pre-specified Outcome
Title Time of Maximum Concentration of BCD-085 After Single Subcutaneous Injection
Hide Description [Not Specified]
Time Frame 57 days
Outcome Measure Data Not Reported
4.Other Pre-specified Outcome
Title Half-life of BCD-085 After Single Subcutaneous Injection
Hide Description [Not Specified]
Time Frame 57 days
Outcome Measure Data Not Reported
5.Other Pre-specified Outcome
Title Constant of Elimination of BCD-085 After Single Subcutaneous Injection
Hide Description [Not Specified]
Time Frame 57 days
Outcome Measure Data Not Reported
6.Other Pre-specified Outcome
Title Clearance of BCD-085 After Single Subcutaneous Injection
Hide Description [Not Specified]
Time Frame 57 days
Outcome Measure Data Not Reported
7.Other Pre-specified Outcome
Title Mean Pain Score by VAS Assessment During Injection of BCD-085
Hide Description [Not Specified]
Time Frame day 1
Outcome Measure Data Not Reported
8.Other Pre-specified Outcome
Title Total Frequency of AE/SAE
Hide Description [Not Specified]
Time Frame 57 days
Outcome Measure Data Not Reported
9.Other Pre-specified Outcome
Title Frequency of Local Reactions
Hide Description [Not Specified]
Time Frame 57 days
Outcome Measure Data Not Reported
10.Other Pre-specified Outcome
Title Frequency of Grade 3-4 AEs
Hide Description [Not Specified]
Time Frame 57 days
Outcome Measure Data Not Reported
11.Other Pre-specified Outcome
Title Frequency of Early Discontinuation Due to AE
Hide Description [Not Specified]
Time Frame 57 days
Outcome Measure Data Not Reported
12.Other Pre-specified Outcome
Title Frequency of Binding Antibodies to BCD-85 Formation
Hide Description [Not Specified]
Time Frame day 57
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cohort no.1 Cohort no.2 Cohort no.3 Cohort no.4 Cohort no.5 Cohort no.6 Cohort no.7 Cohort no.8
Hide Arm/Group Description This cohort includes just one subject who received the maximum safe starting dose of BCD-085 (0.05 mg/kg) subcutaneously. This cohort includes 3 subjects who received the single subcutaneous injection of BCD-085 at a dose of 0.05 mg/kg. This cohort includes 3 subjects who received the single subcutaneous injection of BCD-085 at a dose of 0.25 mg/kg. This cohort includes 3 subjects who received the single subcutaneous injection of BCD-085 at a dose of 0.825 mg/kg. This cohort includes 3 subjects who received the single subcutaneous injection of BCD-085 at a dose of 1.25 mg/kg. This cohort includes 3 subjects who received the single subcutaneous injection of BCD-085 at a dose of 1.75 mg/kg. This cohort includes 3 subjects who received the single subcutaneous injection of BCD-085 at a dose of 2.25 mg/kg. This cohort includes 3 subjects who received the single subcutaneous injection of BCD-085 at a dose of 3.0 mg/kg.
All-Cause Mortality
Cohort no.1 Cohort no.2 Cohort no.3 Cohort no.4 Cohort no.5 Cohort no.6 Cohort no.7 Cohort no.8
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--    
Hide Serious Adverse Events
Cohort no.1 Cohort no.2 Cohort no.3 Cohort no.4 Cohort no.5 Cohort no.6 Cohort no.7 Cohort no.8
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/1 (0.00%)      0/3 (0.00%)      1/3 (33.33%)      0/3 (0.00%)      0/3 (0.00%)      0/3 (0.00%)      0/3 (0.00%)      0/3 (0.00%)    
Injury, poisoning and procedural complications                 
Traumatic brain injury   0/1 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cohort no.1 Cohort no.2 Cohort no.3 Cohort no.4 Cohort no.5 Cohort no.6 Cohort no.7 Cohort no.8
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/1 (100.00%)      0/3 (0.00%)      1/3 (33.33%)      0/3 (0.00%)      2/3 (66.67%)      1/3 (33.33%)      0/3 (0.00%)      0/3 (0.00%)    
Blood and lymphatic system disorders                 
Neutropenia   0/1 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Hepatobiliary disorders                 
Elevated ALT   1/1 (100.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Elevated AST   0/1 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%) 
Injury, poisoning and procedural complications                 
Traumatic brain injury   0/1 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Biryulin Andrey
Organization: BIOCAD
Phone: +7812380 49 33 ext 925
EMail: biryulin@biocad.ru
Layout table for additonal information
Responsible Party: Biocad
ClinicalTrials.gov Identifier: NCT02380287    
Other Study ID Numbers: BCD-085-1
First Submitted: March 2, 2015
First Posted: March 5, 2015
Results First Submitted: March 31, 2016
Results First Posted: May 23, 2016
Last Update Posted: May 23, 2016