Trial Outcomes & Findings for Comparative Study of Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of Single Intravenous Doses of BCD-148 and Soliris® (NCT NCT04027803)
NCT ID: NCT04027803
Last Updated: 2020-05-15
Results Overview
AUC0-∞ of eculizumab (the area under the Concentration vs. Time curve from 0 to infinity)
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
78 participants
Primary outcome timeframe
from 0 to 1392 hours post-infusion
Results posted on
2020-05-15
Participant Flow
Participant milestones
| Measure |
BCD-148
39 healthy subjects/ BCD-148: single 900 mg drip infusion given over 25-45 min
BCD-148: single intravenous infusion of 900 mg BCD-148 active substance of BCD-148 is eculizumab - a monoclonal antibody that targets complement protein C5
|
Soliris
39 healthy subjects Soliris: single 900 mg drip infusion given over 25-45 min
Soliris: single intravenous infusion of 900 mg BCD-148 active substance of Soliris is eculizumab - a monoclonal antibody that targets complement protein C5
|
|---|---|---|
|
Overall Study
STARTED
|
39
|
39
|
|
Overall Study
COMPLETED
|
39
|
39
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
BCD-148
n=39 Participants
39 healthy subjects BCD-148: single 900 mg drip infusion given over 25-45 min
BCD-148: single intravenous infusion of 900 mg BCD-148 active substance of BCD-148 is eculizumab - a monoclonal antibody that targets complement protein C5
|
Soliris
n=39 Participants
39 healthy subjects Soliris: single 900 mg drip infusion given over 25-45 min
Soliris: single intravenous infusion of 900 mg BCD-148 active substance of Soliris is eculizumab - a monoclonal antibody that targets complement protein C5
|
Total
n=78 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=39 Participants
|
0 Participants
n=78 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
39 Participants
n=39 Participants
|
39 Participants
n=39 Participants
|
78 Participants
n=78 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=39 Participants
|
0 Participants
n=39 Participants
|
0 Participants
n=78 Participants
|
|
Age, Continuous
|
27 years
n=39 Participants
|
27 years
n=39 Participants
|
27 years
n=78 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=39 Participants
|
0 Participants
n=39 Participants
|
0 Participants
n=78 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=39 Participants
|
39 Participants
n=39 Participants
|
78 Participants
n=78 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=39 Participants
|
0 Participants
n=78 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
0 Participants
n=39 Participants
|
0 Participants
n=78 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=39 Participants
|
0 Participants
n=78 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=39 Participants
|
0 Participants
n=39 Participants
|
0 Participants
n=78 Participants
|
|
Race (NIH/OMB)
White
|
39 Participants
n=39 Participants
|
39 Participants
n=39 Participants
|
78 Participants
n=78 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=39 Participants
|
0 Participants
n=78 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=39 Participants
|
0 Participants
n=78 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Russia
|
39 participants
n=39 Participants
|
39 participants
n=39 Participants
|
78 participants
n=78 Participants
|
PRIMARY outcome
Timeframe: from 0 to 1392 hours post-infusionAUC0-∞ of eculizumab (the area under the Concentration vs. Time curve from 0 to infinity)
Outcome measures
| Measure |
BCD-148
n=39 Participants
39 healthy subjects/ BCD-148: single 900 mg drip infusion given over 25-45 min
BCD-148: single intravenous infusion of 900 mg BCD-148 active substance of BCD-148 is eculizumab - a monoclonal antibody that targets complement protein C5
|
Soliris
n=39 Participants
39 healthy subjects Soliris: single 900 mg drip infusion given over 25-45 min
Soliris: single intravenous infusion of 900 mg BCD-148 active substance of Soliris is eculizumab - a monoclonal antibody that targets complement protein C5
|
|---|---|---|
|
AUC0-∞ of Eculizumab
|
104346442.41 (ng/ml)*hour
Interval 86711718.872 to 138234664.3
|
114291981.79 (ng/ml)*hour
Interval 95801210.959 to 126281914.98
|
SECONDARY outcome
Timeframe: from 0 to 1392 hours post-infusionCmax of eculizumab (maximum concentration of eculizumab in the serum)
Outcome measures
| Measure |
BCD-148
n=39 Participants
39 healthy subjects/ BCD-148: single 900 mg drip infusion given over 25-45 min
BCD-148: single intravenous infusion of 900 mg BCD-148 active substance of BCD-148 is eculizumab - a monoclonal antibody that targets complement protein C5
|
Soliris
n=39 Participants
39 healthy subjects Soliris: single 900 mg drip infusion given over 25-45 min
Soliris: single intravenous infusion of 900 mg BCD-148 active substance of Soliris is eculizumab - a monoclonal antibody that targets complement protein C5
|
|---|---|---|
|
Cmax of Eculizumab
|
102466648.13 ng/ml
Interval 86216316.914 to 130773188.67
|
112710712.24 ng/ml
Interval 95318606.352 to 125562084.16
|
SECONDARY outcome
Timeframe: from 0 to 1392 hours post-infusionТmax of eculizumab (time to Cmax)
Outcome measures
| Measure |
BCD-148
n=39 Participants
39 healthy subjects/ BCD-148: single 900 mg drip infusion given over 25-45 min
BCD-148: single intravenous infusion of 900 mg BCD-148 active substance of BCD-148 is eculizumab - a monoclonal antibody that targets complement protein C5
|
Soliris
n=39 Participants
39 healthy subjects Soliris: single 900 mg drip infusion given over 25-45 min
Soliris: single intravenous infusion of 900 mg BCD-148 active substance of Soliris is eculizumab - a monoclonal antibody that targets complement protein C5
|
|---|---|---|
|
Тmax of Eculizumab
|
8 hour
Interval 4.0 to 12.0
|
8 hour
Interval 0.083 to 24.0
|
SECONDARY outcome
Timeframe: from 0 to 1392 hours post-infusionAUC0-1392 of eculizumab (the area under the Concentration vs. Time curve from 0 to 1392 h post-infusion)
Outcome measures
| Measure |
BCD-148
n=39 Participants
39 healthy subjects/ BCD-148: single 900 mg drip infusion given over 25-45 min
BCD-148: single intravenous infusion of 900 mg BCD-148 active substance of BCD-148 is eculizumab - a monoclonal antibody that targets complement protein C5
|
Soliris
n=39 Participants
39 healthy subjects Soliris: single 900 mg drip infusion given over 25-45 min
Soliris: single intravenous infusion of 900 mg BCD-148 active substance of Soliris is eculizumab - a monoclonal antibody that targets complement protein C5
|
|---|---|---|
|
AUC0-1392 of Eculizumab
|
102466648.13 (ng/ml)*hour
Interval 86216316.914 to 130773188.67
|
112710712.24 (ng/ml)*hour
Interval 95318606.352 to 125562084.16
|
SECONDARY outcome
Timeframe: from 0 to 1392 hours post-infusionТ1/2 of eculizumab (half-life)
Outcome measures
| Measure |
BCD-148
n=39 Participants
39 healthy subjects/ BCD-148: single 900 mg drip infusion given over 25-45 min
BCD-148: single intravenous infusion of 900 mg BCD-148 active substance of BCD-148 is eculizumab - a monoclonal antibody that targets complement protein C5
|
Soliris
n=39 Participants
39 healthy subjects Soliris: single 900 mg drip infusion given over 25-45 min
Soliris: single intravenous infusion of 900 mg BCD-148 active substance of Soliris is eculizumab - a monoclonal antibody that targets complement protein C5
|
|---|---|---|
|
Т1/2 of Eculizumab
|
165.429 hour
Interval 154.479 to 198.042
|
161.61 hour
Interval 132.711 to 209.22
|
SECONDARY outcome
Timeframe: from 0 to 1392 hours post-infusionVd of eculizumab (steady-state volume of distribution)
Outcome measures
| Measure |
BCD-148
n=39 Participants
39 healthy subjects/ BCD-148: single 900 mg drip infusion given over 25-45 min
BCD-148: single intravenous infusion of 900 mg BCD-148 active substance of BCD-148 is eculizumab - a monoclonal antibody that targets complement protein C5
|
Soliris
n=39 Participants
39 healthy subjects Soliris: single 900 mg drip infusion given over 25-45 min
Soliris: single intravenous infusion of 900 mg BCD-148 active substance of Soliris is eculizumab - a monoclonal antibody that targets complement protein C5
|
|---|---|---|
|
Vd of Eculizumab
|
2595.302 ml
Interval 2118.734 to 3434.689
|
2620.503 ml
Interval 1973.187 to 2984.036
|
SECONDARY outcome
Timeframe: from 0 to 1392 hours post-infusionКel of eculizumab (elimination constant)
Outcome measures
| Measure |
BCD-148
n=39 Participants
39 healthy subjects/ BCD-148: single 900 mg drip infusion given over 25-45 min
BCD-148: single intravenous infusion of 900 mg BCD-148 active substance of BCD-148 is eculizumab - a monoclonal antibody that targets complement protein C5
|
Soliris
n=39 Participants
39 healthy subjects Soliris: single 900 mg drip infusion given over 25-45 min
Soliris: single intravenous infusion of 900 mg BCD-148 active substance of Soliris is eculizumab - a monoclonal antibody that targets complement protein C5
|
|---|---|---|
|
Кel of Eculizumab
|
0.004 1/h
Interval 0.004 to 0.004
|
0.004 1/h
Interval 0.003 to 0.005
|
SECONDARY outcome
Timeframe: from 0 to 1392 hours post-infusionCl of eculizumab (clearance)
Outcome measures
| Measure |
BCD-148
n=39 Participants
39 healthy subjects/ BCD-148: single 900 mg drip infusion given over 25-45 min
BCD-148: single intravenous infusion of 900 mg BCD-148 active substance of BCD-148 is eculizumab - a monoclonal antibody that targets complement protein C5
|
Soliris
n=39 Participants
39 healthy subjects Soliris: single 900 mg drip infusion given over 25-45 min
Soliris: single intravenous infusion of 900 mg BCD-148 active substance of Soliris is eculizumab - a monoclonal antibody that targets complement protein C5
|
|---|---|---|
|
Cl of Eculizumab
|
8.783 ml/(h*kg)
Interval 6.882 to 10.439
|
7.985 ml/(h*kg)
Interval 7.168 to 9.442
|
SECONDARY outcome
Timeframe: from 0 to 1392 hours post-infusionABEC(0-1392) CH50 (the area between the baseline and effect curves for hemolytic activity of serum complement from 0 to 1392 h)
Outcome measures
| Measure |
BCD-148
n=39 Participants
39 healthy subjects/ BCD-148: single 900 mg drip infusion given over 25-45 min
BCD-148: single intravenous infusion of 900 mg BCD-148 active substance of BCD-148 is eculizumab - a monoclonal antibody that targets complement protein C5
|
Soliris
n=39 Participants
39 healthy subjects Soliris: single 900 mg drip infusion given over 25-45 min
Soliris: single intravenous infusion of 900 mg BCD-148 active substance of Soliris is eculizumab - a monoclonal antibody that targets complement protein C5
|
|---|---|---|
|
ABEC(0-1392) CH50
|
-33606.865 (%)*h
Interval -51185.201 to -20772.736
|
-37244.026 (%)*h
Interval -49459.807 to -25247.772
|
SECONDARY outcome
Timeframe: from 0 to 1392 hours post-infusionAUEC(0-1392) CH50 ((area under the Time vs. Effect curve from 0 to 1392 h)
Outcome measures
| Measure |
BCD-148
n=39 Participants
39 healthy subjects/ BCD-148: single 900 mg drip infusion given over 25-45 min
BCD-148: single intravenous infusion of 900 mg BCD-148 active substance of BCD-148 is eculizumab - a monoclonal antibody that targets complement protein C5
|
Soliris
n=39 Participants
39 healthy subjects Soliris: single 900 mg drip infusion given over 25-45 min
Soliris: single intravenous infusion of 900 mg BCD-148 active substance of Soliris is eculizumab - a monoclonal antibody that targets complement protein C5
|
|---|---|---|
|
AUEC(0-1392) CH50
|
61600.835 (%)*h
Interval 45529.369 to 75529.787
|
53479.141 (%)*h
Interval 40111.132 to 72474.492
|
SECONDARY outcome
Timeframe: from 0 to 1392 hours post-infusionEmin CH50 (minimum hemolytic complement activity from 0 to 1392 h)
Outcome measures
| Measure |
BCD-148
n=39 Participants
39 healthy subjects/ BCD-148: single 900 mg drip infusion given over 25-45 min
BCD-148: single intravenous infusion of 900 mg BCD-148 active substance of BCD-148 is eculizumab - a monoclonal antibody that targets complement protein C5
|
Soliris
n=39 Participants
39 healthy subjects Soliris: single 900 mg drip infusion given over 25-45 min
Soliris: single intravenous infusion of 900 mg BCD-148 active substance of Soliris is eculizumab - a monoclonal antibody that targets complement protein C5
|
|---|---|---|
|
Emin CH50
|
0 % of hemolitic activity
Interval 0.0 to 0.0
|
0 % of hemolitic activity
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: from 0 to 1392 hours post-infusionTmin CH50 (time to minimum hemolytic complement activity within the period from 0 to 1392 h)
Outcome measures
| Measure |
BCD-148
n=39 Participants
39 healthy subjects/ BCD-148: single 900 mg drip infusion given over 25-45 min
BCD-148: single intravenous infusion of 900 mg BCD-148 active substance of BCD-148 is eculizumab - a monoclonal antibody that targets complement protein C5
|
Soliris
n=39 Participants
39 healthy subjects Soliris: single 900 mg drip infusion given over 25-45 min
Soliris: single intravenous infusion of 900 mg BCD-148 active substance of Soliris is eculizumab - a monoclonal antibody that targets complement protein C5
|
|---|---|---|
|
Tmin CH50
|
0.083 hour
Interval 0.083 to 0.083
|
0.083 hour
Interval 0.083 to 0.083
|
SECONDARY outcome
Timeframe: from 0 to 1392 hours post-infusionThe percentage of subjects with AEs/SAEs that, in the investigator's opinion, are related to eculizumab
Outcome measures
| Measure |
BCD-148
n=39 Participants
39 healthy subjects/ BCD-148: single 900 mg drip infusion given over 25-45 min
BCD-148: single intravenous infusion of 900 mg BCD-148 active substance of BCD-148 is eculizumab - a monoclonal antibody that targets complement protein C5
|
Soliris
n=39 Participants
39 healthy subjects Soliris: single 900 mg drip infusion given over 25-45 min
Soliris: single intravenous infusion of 900 mg BCD-148 active substance of Soliris is eculizumab - a monoclonal antibody that targets complement protein C5
|
|---|---|---|
|
Subjects With AEs/SAEs Related to Eculizumab
|
28 Participants
|
30 Participants
|
SECONDARY outcome
Timeframe: from 0 to 1392 hours post-infusion• The percentage of subjects with СТСАЕ v. 4.03 grade 3/4 AEs that, in the investigator's opinion, are related to eculizumab, by study arms.
Outcome measures
| Measure |
BCD-148
n=39 Participants
39 healthy subjects/ BCD-148: single 900 mg drip infusion given over 25-45 min
BCD-148: single intravenous infusion of 900 mg BCD-148 active substance of BCD-148 is eculizumab - a monoclonal antibody that targets complement protein C5
|
Soliris
n=39 Participants
39 healthy subjects Soliris: single 900 mg drip infusion given over 25-45 min
Soliris: single intravenous infusion of 900 mg BCD-148 active substance of Soliris is eculizumab - a monoclonal antibody that targets complement protein C5
|
|---|---|---|
|
Subjects Who Develop Grade 3/4 AEs Related to Eculizumab
|
3 Participants
|
0 Participants
|
Adverse Events
BCD-148
Serious events: 0 serious events
Other events: 28 other events
Deaths: 0 deaths
Soliris
Serious events: 0 serious events
Other events: 31 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
BCD-148
n=39 participants at risk
39 healthy subjects/ BCD-148: single 900 mg drip infusion given over 25-45 min
BCD-148: single intravenous infusion of 900 mg BCD-148 active substance of BCD-148 is eculizumab - a monoclonal antibody that targets complement protein C5
|
Soliris
n=39 participants at risk
39 healthy subjects Soliris: single 900 mg drip infusion given over 25-45 min
Soliris: single intravenous infusion of 900 mg BCD-148 active substance of Soliris is eculizumab - a monoclonal antibody that targets complement protein C5
|
|---|---|---|
|
Blood and lymphatic system disorders
anemia
|
17.9%
7/39 • 82 days
|
23.1%
9/39 • 82 days
|
|
Blood and lymphatic system disorders
eosinophils count increase
|
5.1%
2/39 • 82 days
|
2.6%
1/39 • 82 days
|
|
Blood and lymphatic system disorders
lymphocytosis
|
12.8%
5/39 • 82 days
|
10.3%
4/39 • 82 days
|
|
Blood and lymphatic system disorders
lymphopenia
|
10.3%
4/39 • 82 days
|
15.4%
6/39 • 82 days
|
|
Blood and lymphatic system disorders
monocytes count increase
|
7.7%
3/39 • 82 days
|
0.00%
0/39 • 82 days
|
|
Blood and lymphatic system disorders
neutropenia
|
28.2%
11/39 • 82 days
|
23.1%
9/39 • 82 days
|
|
Blood and lymphatic system disorders
platelet count decrease
|
2.6%
1/39 • 82 days
|
5.1%
2/39 • 82 days
|
|
Investigations
ESR increase
|
35.9%
14/39 • 82 days
|
25.6%
10/39 • 82 days
|
|
Investigations
INR decrease
|
12.8%
5/39 • 82 days
|
17.9%
7/39 • 82 days
|
|
Investigations
prothrombin time decreased
|
12.8%
5/39 • 82 days
|
17.9%
7/39 • 82 days
|
|
Investigations
prothrombin time increased
|
5.1%
2/39 • 82 days
|
2.6%
1/39 • 82 days
|
|
Blood and lymphatic system disorders
leukopenia
|
23.1%
9/39 • 82 days
|
17.9%
7/39 • 82 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place