Trial Outcomes & Findings for Study of Pharmacokinetics, Pharmacodynamics, Safety of BCD-131 Compared to Mircera and Aranesp in Healthy Volunteers (NCT NCT02731469)

Results Overview

Area under curve (AUC) "concentration - time" from 0 hours to 1176 hours and to infinity

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

45 participants

Primary outcome timeframe

0, 15 min, 30 min; 60 min; 2 h, 4 h; 8 h, 24 h, 48 h, 72 h, 96 h, 120 h, 168 h, 216 h, 288 h, 336 h, 504 h, 672 h, 840 h, 1008 h, 1176 h post dose

Results posted on

2019-07-01

Participant Flow

Participant milestones

Participant milestones
Measure	BCD-131, 0.05 mcg/kg Subcutaneously Healthy volunteers received BCD-131 in a dose 0.05 mcg/kg subcutaneously BCD-131	BCD-131, 0.15 mcg/kg Subcutaneously Healthy volunteers received BCD-131 in a dose 0.15 mcg/kg subcutaneously BCD-131	BCD-131, 0.40 mcg/kg Subcutaneously Healthy volunteers received BCD-131 in a dose 0.40 mcg/kg subcutaneously BCD-131	BCD-131, 1.05 mcg/kg Subcutaneously Healthy volunteers received BCD-131 in a dose 1.05 mcg/kg subcutaneously BCD-131	BCD-131, 1.70 mcg/kg SC Healthy volunteers received BCD-131 in a dose 1.70 mcg/kg subcutaneously BCD-131	BCD-131, 2.25 mcg/kg SC Healthy volunteers received BCD-131 in a dose 2.25 mcg/kg subcutaneously BCD-131	BCD-131, 4.45 mcg/kg Subcutaneously Healthy volunteers received BCD-131 in a dose 4.45 mcg/kg subcutaneously BCD-131	Mircera®, 1.20 mcg/kg Subcutaneously Healthy volunteers received Mircera in a dose 1.20 mcg/kg subcutaneously Mircera®	Aranesp®, 0.45 mcg/kg Subcutaneously Healthy volunteers received BCD-131 in a dose 0.45 mcg/kg subcutaneously Aranesp®	BCD-131, Optimal Dose, Intravenously Healthy volunteers received BCD-131 in optimal dose - 2,75 mcg/kg determined on first stage of clinical trial intravenously BCD-131	BCD-131, Optimal Dose, Subcutaneously Healthy volunteers will receive BCD-131 in optimal dose - 2,75 mcg/kgdetermined on first stage of clinical trial subcutaneously BCD-131
Overall Study STARTED	3	3	3	3	3	3	3	6	6	6	6
Overall Study COMPLETED	3	3	3	3	3	3	3	6	6	6	6
Overall Study NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of Pharmacokinetics, Pharmacodynamics, Safety of BCD-131 Compared to Mircera and Aranesp in Healthy Volunteers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	BCD-131, 0.05 mcg/kg Subcutaneously n=3 Participants Healthy volunteers received BCD-131 in a dose 0.05 mcg/kg subcutaneously BCD-131	BCD-131, 0.15 mcg/kg Subcutaneously n=3 Participants Healthy volunteers received BCD-131 in a dose 0.15 mcg/kg subcutaneously BCD-131	BCD-131, 0.40 mcg/kg Subcutaneously n=3 Participants Healthy volunteers received BCD-131 in a dose 0.40 mcg/kg subcutaneously BCD-131	BCD-131, 1.05 mcg/kg Subcutaneously n=3 Participants Healthy volunteers received BCD-131 in a dose 1.05 mcg/kg subcutaneously BCD-131	BCD-131, 1.70 mcg/kg SC n=3 Participants Healthy volunteers received BCD-131 in a dose 1.70 mcg/kg subcutaneously BCD-131	BCD-131, 2.25 mcg/kg SC n=3 Participants Healthy volunteers received BCD-131 in a dose 2.25 mcg/kg subcutaneously BCD-131	BCD-131, 4.45 mcg/kg Subcutaneously n=3 Participants Healthy volunteers received BCD-131 in a dose 4.45 mcg/kg subcutaneously BCD-131	Mircera®, 1.20 mcg/kg Subcutaneously n=6 Participants Healthy volunteers received Mircera in a dose 1.20 mcg/kg subcutaneously Mircera®	Aranesp®, 0.45 mcg/kg Subcutaneously n=6 Participants Healthy volunteers received BCD-131 in a dose 0.45 mcg/kg subcutaneously Aranesp®	BCD-131, Optimal Dose, Intravenously n=6 Participants Healthy volunteers received BCD-131 in optimal dose - 2,75 mcg/kg determined on first stage of clinical trial intravenously BCD-131	BCD-131, Optimal Dose, Subcutaneously n=6 Participants Healthy volunteers will receive BCD-131 in optimal dose - 2,75 mcg/kgdetermined on first stage of clinical trial subcutaneously BCD-131	Total n=45 Participants Total of all reporting groups
Age, Continuous	24 years n=5 Participants	26 years n=7 Participants	30 years n=5 Participants	32 years n=4 Participants	26 years n=21 Participants	25 years n=8 Participants	25 years n=8 Participants	28 years n=24 Participants	28 years n=42 Participants	24 years n=42 Participants	25 years n=42 Participants	26 years n=42 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	3 Participants n=21 Participants	3 Participants n=8 Participants	3 Participants n=8 Participants	6 Participants n=24 Participants	6 Participants n=42 Participants	6 Participants n=42 Participants	6 Participants n=42 Participants	45 Participants n=42 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	3 Participants n=21 Participants	3 Participants n=8 Participants	3 Participants n=8 Participants	6 Participants n=24 Participants	6 Participants n=42 Participants	6 Participants n=42 Participants	6 Participants n=42 Participants	45 Participants n=42 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants

PRIMARY outcome

Timeframe: 0, 15 min, 30 min; 60 min; 2 h, 4 h; 8 h, 24 h, 48 h, 72 h, 96 h, 120 h, 168 h, 216 h, 288 h, 336 h, 504 h, 672 h, 840 h, 1008 h, 1176 h post dose

Area under curve (AUC) "concentration - time" from 0 hours to 1176 hours and to infinity

Outcome measures

Outcome measures
Measure	BCD-131, 0.05 mcg/kg Subcutaneously n=3 Participants Healthy volunteers received BCD-131 in a dose 0.05 mcg/kg subcutaneously BCD-131	BCD-131, 0.15 mcg/kg Subcutaneously n=3 Participants Healthy volunteers received BCD-131 in a dose 0.15 mcg/kg subcutaneously BCD-131	BCD-131, 0.40 mcg/kg Subcutaneously n=3 Participants Healthy volunteers received BCD-131 in a dose 0.40 mcg/kg subcutaneously BCD-131	BCD-131, 1.05 mcg/kg Subcutaneously n=3 Participants Healthy volunteers received BCD-131 in a dose 1.05 mcg/kg subcutaneously BCD-131	BCD-131, 1.70 mcg/kg SC n=3 Participants Healthy volunteers received BCD-131 in a dose 1.70 mcg/kg subcutaneously BCD-131	BCD-131, 2.25 mcg/kg SC n=3 Participants Healthy volunteers received BCD-131 in a dose 2.25 mcg/kg subcutaneously BCD-131	BCD-131, 4.45 mcg/kg Subcutaneously n=3 Participants Healthy volunteers received BCD-131 in a dose 4.45 mcg/kg subcutaneously BCD-131	Mircera®, 1.20 mcg/kg Subcutaneously n=6 Participants Healthy volunteers received Mircera in a dose 1.20 mcg/kg subcutaneously Mircera®	Aranesp®, 0.45 mcg/kg Subcutaneously n=6 Participants Healthy volunteers received BCD-131 in a dose 0.45 mcg/kg subcutaneously Aranesp®	BCD-131, Optimal Dose, Intravenously n=6 Participants Healthy volunteers received BCD-131 in optimal dose - 2,75 mcg/kg determined on first stage of clinical trial intravenously BCD-131	BCD-131, Optimal Dose, Subcutaneously n=6 Participants Healthy volunteers will receive BCD-131 in optimal dose - 2,75 mcg/kgdetermined on first stage of clinical trial subcutaneously BCD-131
AUC (0-1176 Hours)	206974.500 pg*hr/ml Interval 144988.5 to 485443.5	657417.000 pg*hr/ml Interval 598401.5 to 666088.5	827904.750 pg*hr/ml Interval 362302.0 to 1179816.5	1360020.000 pg*hr/ml Interval 424094.0 to 1427990.75	1314197.750 pg*hr/ml Interval 64430.0 to 1465335.5	3202606.500 pg*hr/ml Interval 2173496.25 to 4300376.0	5220198.750 pg*hr/ml Interval 4658082.25 to 5328878.25	688124.000 pg*hr/ml Interval 478496.0 to 1252376.25	94628.375 pg*hr/ml Interval 49807.25 to 113412.5	6382389.188 pg*hr/ml Interval 4818041.5 to 6826251.75	2089193.125 pg*hr/ml Interval 789943.0 to 2926898.0

SECONDARY outcome

Timeframe: 0, 15 min, 30 min; 60 min; 2 h, 4 h; 8 h, 24 h, 48 h, 72 h, 96 h, 120 h, 168 h, 216 h, 288 h, 336 h, 504 h, 672 h, 840 h, 1008 h, 1176 hours post-dose

Maximal concentration of drug in blood after single injection

Outcome measures

Outcome measures
Measure	BCD-131, 0.05 mcg/kg Subcutaneously n=3 Participants Healthy volunteers received BCD-131 in a dose 0.05 mcg/kg subcutaneously BCD-131	BCD-131, 0.15 mcg/kg Subcutaneously n=3 Participants Healthy volunteers received BCD-131 in a dose 0.15 mcg/kg subcutaneously BCD-131	BCD-131, 0.40 mcg/kg Subcutaneously n=3 Participants Healthy volunteers received BCD-131 in a dose 0.40 mcg/kg subcutaneously BCD-131	BCD-131, 1.05 mcg/kg Subcutaneously n=3 Participants Healthy volunteers received BCD-131 in a dose 1.05 mcg/kg subcutaneously BCD-131	BCD-131, 1.70 mcg/kg SC n=3 Participants Healthy volunteers received BCD-131 in a dose 1.70 mcg/kg subcutaneously BCD-131	BCD-131, 2.25 mcg/kg SC n=3 Participants Healthy volunteers received BCD-131 in a dose 2.25 mcg/kg subcutaneously BCD-131	BCD-131, 4.45 mcg/kg Subcutaneously n=3 Participants Healthy volunteers received BCD-131 in a dose 4.45 mcg/kg subcutaneously BCD-131	Mircera®, 1.20 mcg/kg Subcutaneously n=6 Participants Healthy volunteers received Mircera in a dose 1.20 mcg/kg subcutaneously Mircera®	Aranesp®, 0.45 mcg/kg Subcutaneously n=6 Participants Healthy volunteers received BCD-131 in a dose 0.45 mcg/kg subcutaneously Aranesp®	BCD-131, Optimal Dose, Intravenously n=6 Participants Healthy volunteers received BCD-131 in optimal dose - 2,75 mcg/kg determined on first stage of clinical trial intravenously BCD-131	BCD-131, Optimal Dose, Subcutaneously n=6 Participants Healthy volunteers will receive BCD-131 in optimal dose - 2,75 mcg/kgdetermined on first stage of clinical trial subcutaneously BCD-131
Cmax	585.000 picogram per ml Interval 503.0 to 744.0	1035.000 picogram per ml Interval 854.0 to 1761.0	2248.000 picogram per ml Interval 1457.0 to 2566.0	3634.000 picogram per ml Interval 2924.0 to 4954.0	3541.000 picogram per ml Interval 150.0 to 4110.0	12023.000 picogram per ml Interval 6863.0 to 12243.0	15433.000 picogram per ml Interval 13286.0 to 16404.0	2298.000 picogram per ml Interval 1849.0 to 6867.0	964.500 picogram per ml Interval 870.0 to 1229.0	87526.5 picogram per ml Interval 69859.0 to 93090.0	10588 picogram per ml Interval 3713.0 to 11692.0

SECONDARY outcome

Timeframe: 0, 15 min, 30 min; 60 min; 2 h, 4 h; 8 h, 24 h, 48 h, 72 h, 96 h, 120 h, 168 h, 216 h, 288 h, 336 h, 504 h, 672 h, 840 h, 1008 h, 1176 hours post-dose

Time from 9 hours to time of maximal concentration of drug in blood after single injection

Outcome measures

Outcome measures
Measure	BCD-131, 0.05 mcg/kg Subcutaneously n=3 Participants Healthy volunteers received BCD-131 in a dose 0.05 mcg/kg subcutaneously BCD-131	BCD-131, 0.15 mcg/kg Subcutaneously n=3 Participants Healthy volunteers received BCD-131 in a dose 0.15 mcg/kg subcutaneously BCD-131	BCD-131, 0.40 mcg/kg Subcutaneously n=3 Participants Healthy volunteers received BCD-131 in a dose 0.40 mcg/kg subcutaneously BCD-131	BCD-131, 1.05 mcg/kg Subcutaneously n=3 Participants Healthy volunteers received BCD-131 in a dose 1.05 mcg/kg subcutaneously BCD-131	BCD-131, 1.70 mcg/kg SC n=3 Participants Healthy volunteers received BCD-131 in a dose 1.70 mcg/kg subcutaneously BCD-131	BCD-131, 2.25 mcg/kg SC n=3 Participants Healthy volunteers received BCD-131 in a dose 2.25 mcg/kg subcutaneously BCD-131	BCD-131, 4.45 mcg/kg Subcutaneously n=3 Participants Healthy volunteers received BCD-131 in a dose 4.45 mcg/kg subcutaneously BCD-131	Mircera®, 1.20 mcg/kg Subcutaneously n=6 Participants Healthy volunteers received Mircera in a dose 1.20 mcg/kg subcutaneously Mircera®	Aranesp®, 0.45 mcg/kg Subcutaneously n=6 Participants Healthy volunteers received BCD-131 in a dose 0.45 mcg/kg subcutaneously Aranesp®	BCD-131, Optimal Dose, Intravenously n=6 Participants Healthy volunteers received BCD-131 in optimal dose - 2,75 mcg/kg determined on first stage of clinical trial intravenously BCD-131	BCD-131, Optimal Dose, Subcutaneously n=6 Participants Healthy volunteers will receive BCD-131 in optimal dose - 2,75 mcg/kgdetermined on first stage of clinical trial subcutaneously BCD-131
Tmax	216.000 hours Interval 96.0 to 504.0	168.000 hours Interval 72.0 to 504.0	96.000 hours Interval 8.0 to 96.0	72.000 hours Interval 48.0 to 72.0	72.000 hours Interval 48.0 to 168.0	120.000 hours Interval 96.0 to 168.0	96.000 hours Interval 72.0 to 96.0	48.000 hours Interval 48.0 to 72.0	36.000 hours Interval 8.0 to 36.0	0.75 hours Interval 0.5 to 1.0	84 hours Interval 72.0 to 96.0

SECONDARY outcome

Timeframe: 0, 15 min, 30 min; 60 min; 2 h, 4 h; 8 h, 24 h, 48 h, 72 h, 96 h, 120 h, 168 h, 216 h, 288 h, 336 h, 504 h, 672 h, 840 h, 1008 h, 1176 hours post-dose

Population: the calculation of the half-life in group 0,15 mcg/kg was not carried out, due to the lack of a linear terminal phase of elimination in volunteers

Half-life of drug in blood after single injection. In the coрort BCD-131 0,15 mcg/kg due to the absence of a linear terminal elimination phase in volunteers, the calculation of T1 / 2 was not possible

Outcome measures

Outcome measures
Measure	BCD-131, 0.05 mcg/kg Subcutaneously n=3 Participants Healthy volunteers received BCD-131 in a dose 0.05 mcg/kg subcutaneously BCD-131	BCD-131, 0.15 mcg/kg Subcutaneously Healthy volunteers received BCD-131 in a dose 0.15 mcg/kg subcutaneously BCD-131	BCD-131, 0.40 mcg/kg Subcutaneously n=3 Participants Healthy volunteers received BCD-131 in a dose 0.40 mcg/kg subcutaneously BCD-131	BCD-131, 1.05 mcg/kg Subcutaneously n=3 Participants Healthy volunteers received BCD-131 in a dose 1.05 mcg/kg subcutaneously BCD-131	BCD-131, 1.70 mcg/kg SC n=3 Participants Healthy volunteers received BCD-131 in a dose 1.70 mcg/kg subcutaneously BCD-131	BCD-131, 2.25 mcg/kg SC n=3 Participants Healthy volunteers received BCD-131 in a dose 2.25 mcg/kg subcutaneously BCD-131	BCD-131, 4.45 mcg/kg Subcutaneously n=3 Participants Healthy volunteers received BCD-131 in a dose 4.45 mcg/kg subcutaneously BCD-131	Mircera®, 1.20 mcg/kg Subcutaneously n=6 Participants Healthy volunteers received Mircera in a dose 1.20 mcg/kg subcutaneously Mircera®	Aranesp®, 0.45 mcg/kg Subcutaneously n=6 Participants Healthy volunteers received BCD-131 in a dose 0.45 mcg/kg subcutaneously Aranesp®	BCD-131, Optimal Dose, Intravenously n=6 Participants Healthy volunteers received BCD-131 in optimal dose - 2,75 mcg/kg determined on first stage of clinical trial intravenously BCD-131	BCD-131, Optimal Dose, Subcutaneously n=6 Participants Healthy volunteers will receive BCD-131 in optimal dose - 2,75 mcg/kgdetermined on first stage of clinical trial subcutaneously BCD-131
T1/2	322.094 hours Interval 322.094 to 322.094	—	377.272 hours Interval 281.082 to 473.461	212.231 hours Interval 212.231 to 212.231	416.482 hours Interval 326.648 to 506.316	191.477 hours Interval 145.071 to 495.813	181.310 hours Interval 168.649 to 186.681	114.855 hours Interval 105.888 to 256.031	79.473 hours Interval 44.619 to 104.605	116.125 hours Interval 70.7 to 120.38	182.392 hours Interval 123.71 to 197.76

SECONDARY outcome

Timeframe: 0, 15 min, 30 min; 60 min; 2 h, 4 h; 8 h, 24 h, 48 h, 72 h, 96 h, 120 h, 168 h, 216 h, 288 h, 336 h, 504 h, 672 h, 840 h, 1008 h, 1176 hours post-dose

Population: the calculation of the Kel in group "0,15 mcg/kg" was not carried out, due to the lack of a linear terminal phase of elimination in volunteers

Elimination rate constant of drug in blood after single injection. In the cohort BCD-131 0,15 mcg/kg due to the absence of a linear terminal elimination phase in volunteers, the calculation of Kel was not possible

Outcome measures

Outcome measures
Measure	BCD-131, 0.05 mcg/kg Subcutaneously n=3 Participants Healthy volunteers received BCD-131 in a dose 0.05 mcg/kg subcutaneously BCD-131	BCD-131, 0.15 mcg/kg Subcutaneously Healthy volunteers received BCD-131 in a dose 0.15 mcg/kg subcutaneously BCD-131	BCD-131, 0.40 mcg/kg Subcutaneously n=3 Participants Healthy volunteers received BCD-131 in a dose 0.40 mcg/kg subcutaneously BCD-131	BCD-131, 1.05 mcg/kg Subcutaneously n=3 Participants Healthy volunteers received BCD-131 in a dose 1.05 mcg/kg subcutaneously BCD-131	BCD-131, 1.70 mcg/kg SC n=3 Participants Healthy volunteers received BCD-131 in a dose 1.70 mcg/kg subcutaneously BCD-131	BCD-131, 2.25 mcg/kg SC n=3 Participants Healthy volunteers received BCD-131 in a dose 2.25 mcg/kg subcutaneously BCD-131	BCD-131, 4.45 mcg/kg Subcutaneously n=3 Participants Healthy volunteers received BCD-131 in a dose 4.45 mcg/kg subcutaneously BCD-131	Mircera®, 1.20 mcg/kg Subcutaneously n=6 Participants Healthy volunteers received Mircera in a dose 1.20 mcg/kg subcutaneously Mircera®	Aranesp®, 0.45 mcg/kg Subcutaneously n=6 Participants Healthy volunteers received BCD-131 in a dose 0.45 mcg/kg subcutaneously Aranesp®	BCD-131, Optimal Dose, Intravenously n=6 Participants Healthy volunteers received BCD-131 in optimal dose - 2,75 mcg/kg determined on first stage of clinical trial intravenously BCD-131	BCD-131, Optimal Dose, Subcutaneously n=6 Participants Healthy volunteers will receive BCD-131 in optimal dose - 2,75 mcg/kgdetermined on first stage of clinical trial subcutaneously BCD-131
Kel	0.002152 fraction per hour Interval 0.002152 to 0.002152	—	0.001965 fraction per hour Interval 0.001464 to 0.002466	0.003266 fraction per hour Interval 0.003266 to 0.003266	0.001746 fraction per hour Interval 0.001369 to 0.002122	0.003620 fraction per hour Interval 0.001398 to 0.004778	0.003823 fraction per hour Interval 0.003713 to 0.00411	0.006057 fraction per hour Interval 0.003734 to 0.006549	0.009019 fraction per hour Interval 0.006697 to 0.019655	0.005977 fraction per hour Interval 0.003424 to 0.006196	0.003828 fraction per hour Interval 0.001367 to 0.00415

SECONDARY outcome

Timeframe: 0, 15 min, 30 min; 60 min; 2 h, 4 h; 8 h, 24 h, 48 h, 72 h, 96 h, 120 h, 168 h, 216 h, 288 h, 336 h, 504 h, 672 h, 840 h, 1008 h, 1176 hours post-dose

Clearance of BCD-131 in blood after single injection

Outcome measures

Outcome measures
Measure	BCD-131, 0.05 mcg/kg Subcutaneously n=3 Participants Healthy volunteers received BCD-131 in a dose 0.05 mcg/kg subcutaneously BCD-131	BCD-131, 0.15 mcg/kg Subcutaneously n=3 Participants Healthy volunteers received BCD-131 in a dose 0.15 mcg/kg subcutaneously BCD-131	BCD-131, 0.40 mcg/kg Subcutaneously n=3 Participants Healthy volunteers received BCD-131 in a dose 0.40 mcg/kg subcutaneously BCD-131	BCD-131, 1.05 mcg/kg Subcutaneously n=3 Participants Healthy volunteers received BCD-131 in a dose 1.05 mcg/kg subcutaneously BCD-131	BCD-131, 1.70 mcg/kg SC n=3 Participants Healthy volunteers received BCD-131 in a dose 1.70 mcg/kg subcutaneously BCD-131	BCD-131, 2.25 mcg/kg SC n=3 Participants Healthy volunteers received BCD-131 in a dose 2.25 mcg/kg subcutaneously BCD-131	BCD-131, 4.45 mcg/kg Subcutaneously n=3 Participants Healthy volunteers received BCD-131 in a dose 4.45 mcg/kg subcutaneously BCD-131	Mircera®, 1.20 mcg/kg Subcutaneously n=6 Participants Healthy volunteers received Mircera in a dose 1.20 mcg/kg subcutaneously Mircera®	Aranesp®, 0.45 mcg/kg Subcutaneously n=6 Participants Healthy volunteers received BCD-131 in a dose 0.45 mcg/kg subcutaneously Aranesp®	BCD-131, Optimal Dose, Intravenously n=6 Participants Healthy volunteers received BCD-131 in optimal dose - 2,75 mcg/kg determined on first stage of clinical trial intravenously BCD-131	BCD-131, Optimal Dose, Subcutaneously n=6 Participants Healthy volunteers will receive BCD-131 in optimal dose - 2,75 mcg/kgdetermined on first stage of clinical trial subcutaneously BCD-131
Clearance of BCD-131	17.393 ml per hour Interval 8.446 to 24.14	16.200 ml per hour Interval 15.313 to 21.808	33.337 ml per hour Interval 24.411 to 83.908	54.043 ml per hour Interval 48.53 to 225.304	92.812 ml per hour Interval 91.843 to 1820.58	65.259 ml per hour Interval 46.682 to 88.567	51.774 ml per hour Interval 51.147 to 57.32	108.993 ml per hour Interval 59.886 to 156.741	332.263 ml per hour Interval 304.017 to 602.322	29.84 ml per hour Interval 24.293 to 30.734	136.391 ml per hour Interval 48.481 to 202.399

SECONDARY outcome

Timeframe: 0, 24 h, 48 h; 72 h; 96 h; 120 h; 168 h; 216 h; 288 h; 336 h, 504 h; 672 h; 840 h; 1008 h; 1176 h post-dose

Area under effect curve (AUEC) "absolute reticulocyte count - time" from 0 to 1176 hours post-dose after single injection of study drug

Outcome measures

Outcome measures
Measure	BCD-131, 0.05 mcg/kg Subcutaneously n=3 Participants Healthy volunteers received BCD-131 in a dose 0.05 mcg/kg subcutaneously BCD-131	BCD-131, 0.15 mcg/kg Subcutaneously n=3 Participants Healthy volunteers received BCD-131 in a dose 0.15 mcg/kg subcutaneously BCD-131	BCD-131, 0.40 mcg/kg Subcutaneously n=3 Participants Healthy volunteers received BCD-131 in a dose 0.40 mcg/kg subcutaneously BCD-131	BCD-131, 1.05 mcg/kg Subcutaneously n=3 Participants Healthy volunteers received BCD-131 in a dose 1.05 mcg/kg subcutaneously BCD-131	BCD-131, 1.70 mcg/kg SC n=3 Participants Healthy volunteers received BCD-131 in a dose 1.70 mcg/kg subcutaneously BCD-131	BCD-131, 2.25 mcg/kg SC n=3 Participants Healthy volunteers received BCD-131 in a dose 2.25 mcg/kg subcutaneously BCD-131	BCD-131, 4.45 mcg/kg Subcutaneously n=3 Participants Healthy volunteers received BCD-131 in a dose 4.45 mcg/kg subcutaneously BCD-131	Mircera®, 1.20 mcg/kg Subcutaneously n=6 Participants Healthy volunteers received Mircera in a dose 1.20 mcg/kg subcutaneously Mircera®	Aranesp®, 0.45 mcg/kg Subcutaneously n=6 Participants Healthy volunteers received BCD-131 in a dose 0.45 mcg/kg subcutaneously Aranesp®	BCD-131, Optimal Dose, Intravenously n=6 Participants Healthy volunteers received BCD-131 in optimal dose - 2,75 mcg/kg determined on first stage of clinical trial intravenously BCD-131	BCD-131, Optimal Dose, Subcutaneously n=6 Participants Healthy volunteers will receive BCD-131 in optimal dose - 2,75 mcg/kgdetermined on first stage of clinical trial subcutaneously BCD-131
AUEC (0-1176 Hours) - Reticulocytes	10568.04 cells (10^9) * hr/l Interval 10107.6 to 10940.76	348.000 cells (10^9) * hr/l Interval 144.0 to 1980.0	2868.000 cells (10^9) * hr/l Interval 2664.0 to 17556.0	11004.00 cells (10^9) * hr/l Interval 6006.0 to 13416.0	14481.60 cells (10^9) * hr/l Interval 10366.8 to 15530.4	25512.00 cells (10^9) * hr/l Interval 16476.0 to 30355.2	69120.00 cells (10^9) * hr/l Interval 46183.2 to 81511.2	10269.72 cells (10^9) * hr/l Interval 3121.2 to 16310.88	14223.60 cells (10^9) * hr/l Interval 8736.0 to 21257.28	21370.44 cells (10^9) * hr/l Interval 18081.6 to 22724.88	13129.2 cells (10^9) * hr/l Interval 4432.56 to 15072.0

SECONDARY outcome

Timeframe: 0, 24 h, 48 h; 72 h; 96 h; 120 h; 168 h; 216 h; 288 h; 336 h, 504 h; 672 h; 840 h; 1008 h; 1176 h post-dose

Area under effect curve (AUEC) "hemoglobin - time" from 0 to 1176 hours post-dose after single injection of study drug

Outcome measures

Outcome measures
Measure	BCD-131, 0.05 mcg/kg Subcutaneously n=3 Participants Healthy volunteers received BCD-131 in a dose 0.05 mcg/kg subcutaneously BCD-131	BCD-131, 0.15 mcg/kg Subcutaneously n=3 Participants Healthy volunteers received BCD-131 in a dose 0.15 mcg/kg subcutaneously BCD-131	BCD-131, 0.40 mcg/kg Subcutaneously n=3 Participants Healthy volunteers received BCD-131 in a dose 0.40 mcg/kg subcutaneously BCD-131	BCD-131, 1.05 mcg/kg Subcutaneously n=3 Participants Healthy volunteers received BCD-131 in a dose 1.05 mcg/kg subcutaneously BCD-131	BCD-131, 1.70 mcg/kg SC n=3 Participants Healthy volunteers received BCD-131 in a dose 1.70 mcg/kg subcutaneously BCD-131	BCD-131, 2.25 mcg/kg SC n=3 Participants Healthy volunteers received BCD-131 in a dose 2.25 mcg/kg subcutaneously BCD-131	BCD-131, 4.45 mcg/kg Subcutaneously n=3 Participants Healthy volunteers received BCD-131 in a dose 4.45 mcg/kg subcutaneously BCD-131	Mircera®, 1.20 mcg/kg Subcutaneously n=6 Participants Healthy volunteers received Mircera in a dose 1.20 mcg/kg subcutaneously Mircera®	Aranesp®, 0.45 mcg/kg Subcutaneously n=6 Participants Healthy volunteers received BCD-131 in a dose 0.45 mcg/kg subcutaneously Aranesp®	BCD-131, Optimal Dose, Intravenously n=6 Participants Healthy volunteers received BCD-131 in optimal dose - 2,75 mcg/kg determined on first stage of clinical trial intravenously BCD-131	BCD-131, Optimal Dose, Subcutaneously n=6 Participants Healthy volunteers will receive BCD-131 in optimal dose - 2,75 mcg/kgdetermined on first stage of clinical trial subcutaneously BCD-131
AUEC (0-1176 Hours) - Hemoglobin	864.00 gr*hr/l Interval 528.0 to 2460.0	216.00 gr*hr/l Interval 0.0 to 1260.0	1992.00 gr*hr/l Interval 1152.0 to 3864.0	4752.00 gr*hr/l Interval 2688.0 to 6924.0	1548.00 gr*hr/l Interval 1320.0 to 10128.0	1392.00 gr*hr/l Interval 660.0 to 23460.0	3516.00 gr*hr/l Interval 2904.0 to 4248.0	3492.00 gr*hr/l Interval 720.0 to 6156.0	3120.00 gr*hr/l Interval 2112.0 to 4320.0	4008 gr*hr/l Interval 2340.0 to 4044.0	4632 gr*hr/l Interval 2448.0 to 4812.0

SECONDARY outcome

Timeframe: 0, 24 h, 48 h; 72 h; 96 h; 120 h; 168 h; 216 h; 288 h; 336 h, 504 h; 672 h; 840 h; 1008 h; 1176 h post-dose

Absolute maximum of reticulocyte count (AC-Emax - reticulocytes) after single injection of study drug

Outcome measures

Outcome measures
Measure	BCD-131, 0.05 mcg/kg Subcutaneously n=3 Participants Healthy volunteers received BCD-131 in a dose 0.05 mcg/kg subcutaneously BCD-131	BCD-131, 0.15 mcg/kg Subcutaneously n=3 Participants Healthy volunteers received BCD-131 in a dose 0.15 mcg/kg subcutaneously BCD-131	BCD-131, 0.40 mcg/kg Subcutaneously n=3 Participants Healthy volunteers received BCD-131 in a dose 0.40 mcg/kg subcutaneously BCD-131	BCD-131, 1.05 mcg/kg Subcutaneously n=3 Participants Healthy volunteers received BCD-131 in a dose 1.05 mcg/kg subcutaneously BCD-131	BCD-131, 1.70 mcg/kg SC n=3 Participants Healthy volunteers received BCD-131 in a dose 1.70 mcg/kg subcutaneously BCD-131	BCD-131, 2.25 mcg/kg SC n=3 Participants Healthy volunteers received BCD-131 in a dose 2.25 mcg/kg subcutaneously BCD-131	BCD-131, 4.45 mcg/kg Subcutaneously n=3 Participants Healthy volunteers received BCD-131 in a dose 4.45 mcg/kg subcutaneously BCD-131	Mircera®, 1.20 mcg/kg Subcutaneously n=6 Participants Healthy volunteers received Mircera in a dose 1.20 mcg/kg subcutaneously Mircera®	Aranesp®, 0.45 mcg/kg Subcutaneously n=6 Participants Healthy volunteers received BCD-131 in a dose 0.45 mcg/kg subcutaneously Aranesp®	BCD-131, Optimal Dose, Intravenously n=6 Participants Healthy volunteers received BCD-131 in optimal dose - 2,75 mcg/kg determined on first stage of clinical trial intravenously BCD-131	BCD-131, Optimal Dose, Subcutaneously n=6 Participants Healthy volunteers will receive BCD-131 in optimal dose - 2,75 mcg/kgdetermined on first stage of clinical trial subcutaneously BCD-131
AC-Emax - Reticulocytes	23.65 10e9 reticulocytes per liter" Interval 17.15 to 31.34	6.00 10e9 reticulocytes per liter" Interval 6.0 to 22.0	13.00 10e9 reticulocytes per liter" Interval 11.0 to 34.0	27.00 10e9 reticulocytes per liter" Interval 12.0 to 28.0	20.68 10e9 reticulocytes per liter" Interval 17.0 to 26.0	112.00 10e9 reticulocytes per liter" Interval 81.0 to 132.0	110.00 10e9 reticulocytes per liter" Interval 69.0 to 171.0	58.00 10e9 reticulocytes per liter" Interval 48.0 to 91.42	62.22 10e9 reticulocytes per liter" Interval 48.0 to 153.1	70.18 10e9 reticulocytes per liter" Interval 67.0 to 72.76	57.5 10e9 reticulocytes per liter" Interval 45.4 to 58.0

SECONDARY outcome

Timeframe: 0, 24 h, 48 h; 72 h; 96 h; 120 h; 168 h; 216 h; 288 h; 336 h, 504 h; 672 h; 840 h; 1008 h; 1176 h post-dose

Absolute maximum of hemoglobin (AC-Emax - hemoglobin) after single injection of study drug

Outcome measures

Outcome measures
Measure	BCD-131, 0.05 mcg/kg Subcutaneously n=3 Participants Healthy volunteers received BCD-131 in a dose 0.05 mcg/kg subcutaneously BCD-131	BCD-131, 0.15 mcg/kg Subcutaneously n=3 Participants Healthy volunteers received BCD-131 in a dose 0.15 mcg/kg subcutaneously BCD-131	BCD-131, 0.40 mcg/kg Subcutaneously n=3 Participants Healthy volunteers received BCD-131 in a dose 0.40 mcg/kg subcutaneously BCD-131	BCD-131, 1.05 mcg/kg Subcutaneously n=3 Participants Healthy volunteers received BCD-131 in a dose 1.05 mcg/kg subcutaneously BCD-131	BCD-131, 1.70 mcg/kg SC n=3 Participants Healthy volunteers received BCD-131 in a dose 1.70 mcg/kg subcutaneously BCD-131	BCD-131, 2.25 mcg/kg SC n=3 Participants Healthy volunteers received BCD-131 in a dose 2.25 mcg/kg subcutaneously BCD-131	BCD-131, 4.45 mcg/kg Subcutaneously n=3 Participants Healthy volunteers received BCD-131 in a dose 4.45 mcg/kg subcutaneously BCD-131	Mircera®, 1.20 mcg/kg Subcutaneously n=6 Participants Healthy volunteers received Mircera in a dose 1.20 mcg/kg subcutaneously Mircera®	Aranesp®, 0.45 mcg/kg Subcutaneously n=6 Participants Healthy volunteers received BCD-131 in a dose 0.45 mcg/kg subcutaneously Aranesp®	BCD-131, Optimal Dose, Intravenously n=6 Participants Healthy volunteers received BCD-131 in optimal dose - 2,75 mcg/kg determined on first stage of clinical trial intravenously BCD-131	BCD-131, Optimal Dose, Subcutaneously n=6 Participants Healthy volunteers will receive BCD-131 in optimal dose - 2,75 mcg/kgdetermined on first stage of clinical trial subcutaneously BCD-131
AC-Emax - Hemoglobin	8.00 gramm per liter Interval 3.0 to 11.0	2.00 gramm per liter Interval 0.0 to 22.0	7.00 gramm per liter Interval 5.0 to 9.0	9.00 gramm per liter Interval 8.0 to 15.0	9.00 gramm per liter Interval 6.0 to 21.0	6.00 gramm per liter Interval 4.0 to 26.0	10.00 gramm per liter Interval 8.0 to 10.0	10.50 gramm per liter Interval 3.0 to 12.0	9.00 gramm per liter Interval 8.0 to 13.0	11.00 gramm per liter Interval 8.0 to 13.0	10.5 gramm per liter Interval 9.0 to 12.0

SECONDARY outcome

Timeframe: intraoperative

Population: In second period of study, when healthy volunteers received BCD-131 in optimal dose, visual analoge scale was not applied (by protocol)

visual analog scale Minimum value - 0, Maximum value -10, Higher scores mean worse outcome

Outcome measures

Outcome measures
Measure	BCD-131, 0.05 mcg/kg Subcutaneously n=3 Participants Healthy volunteers received BCD-131 in a dose 0.05 mcg/kg subcutaneously BCD-131	BCD-131, 0.15 mcg/kg Subcutaneously n=3 Participants Healthy volunteers received BCD-131 in a dose 0.15 mcg/kg subcutaneously BCD-131	BCD-131, 0.40 mcg/kg Subcutaneously n=3 Participants Healthy volunteers received BCD-131 in a dose 0.40 mcg/kg subcutaneously BCD-131	BCD-131, 1.05 mcg/kg Subcutaneously n=3 Participants Healthy volunteers received BCD-131 in a dose 1.05 mcg/kg subcutaneously BCD-131	BCD-131, 1.70 mcg/kg SC n=3 Participants Healthy volunteers received BCD-131 in a dose 1.70 mcg/kg subcutaneously BCD-131	BCD-131, 2.25 mcg/kg SC n=3 Participants Healthy volunteers received BCD-131 in a dose 2.25 mcg/kg subcutaneously BCD-131	BCD-131, 4.45 mcg/kg Subcutaneously n=3 Participants Healthy volunteers received BCD-131 in a dose 4.45 mcg/kg subcutaneously BCD-131	Mircera®, 1.20 mcg/kg Subcutaneously n=6 Participants Healthy volunteers received Mircera in a dose 1.20 mcg/kg subcutaneously Mircera®	Aranesp®, 0.45 mcg/kg Subcutaneously n=6 Participants Healthy volunteers received BCD-131 in a dose 0.45 mcg/kg subcutaneously Aranesp®	BCD-131, Optimal Dose, Intravenously Healthy volunteers received BCD-131 in optimal dose - 2,75 mcg/kg determined on first stage of clinical trial intravenously BCD-131	BCD-131, Optimal Dose, Subcutaneously Healthy volunteers will receive BCD-131 in optimal dose - 2,75 mcg/kgdetermined on first stage of clinical trial subcutaneously BCD-131
Intensity of Pain After Subcutaneous Injection According to Visual Analog Scale	0 score on a scale Interval 0.0 to 2.0	0 score on a scale Interval 0.0 to 0.0	0 score on a scale Interval 0.0 to 2.0	2 score on a scale Interval 0.0 to 2.0	2 score on a scale Interval 0.0 to 2.0	0 score on a scale Interval 0.0 to 2.0	2 score on a scale Interval 0.0 to 2.0	0 score on a scale Interval 0.0 to 0.0	2 score on a scale Interval 0.0 to 2.0	—	—

SECONDARY outcome

Timeframe: from the first administartion of the drug up to the end of follow up period (28 days after the last dose of the drug)

Total incidence of adverse events (AE)/ serious adverse events (SAE)

Outcome measures

Outcome measures
Measure	BCD-131, 0.05 mcg/kg Subcutaneously n=3 Participants Healthy volunteers received BCD-131 in a dose 0.05 mcg/kg subcutaneously BCD-131	BCD-131, 0.15 mcg/kg Subcutaneously n=3 Participants Healthy volunteers received BCD-131 in a dose 0.15 mcg/kg subcutaneously BCD-131	BCD-131, 0.40 mcg/kg Subcutaneously n=3 Participants Healthy volunteers received BCD-131 in a dose 0.40 mcg/kg subcutaneously BCD-131	BCD-131, 1.05 mcg/kg Subcutaneously n=3 Participants Healthy volunteers received BCD-131 in a dose 1.05 mcg/kg subcutaneously BCD-131	BCD-131, 1.70 mcg/kg SC n=3 Participants Healthy volunteers received BCD-131 in a dose 1.70 mcg/kg subcutaneously BCD-131	BCD-131, 2.25 mcg/kg SC n=3 Participants Healthy volunteers received BCD-131 in a dose 2.25 mcg/kg subcutaneously BCD-131	BCD-131, 4.45 mcg/kg Subcutaneously n=3 Participants Healthy volunteers received BCD-131 in a dose 4.45 mcg/kg subcutaneously BCD-131	Mircera®, 1.20 mcg/kg Subcutaneously n=6 Participants Healthy volunteers received Mircera in a dose 1.20 mcg/kg subcutaneously Mircera®	Aranesp®, 0.45 mcg/kg Subcutaneously n=6 Participants Healthy volunteers received BCD-131 in a dose 0.45 mcg/kg subcutaneously Aranesp®	BCD-131, Optimal Dose, Intravenously n=6 Participants Healthy volunteers received BCD-131 in optimal dose - 2,75 mcg/kg determined on first stage of clinical trial intravenously BCD-131	BCD-131, Optimal Dose, Subcutaneously n=6 Participants Healthy volunteers will receive BCD-131 in optimal dose - 2,75 mcg/kgdetermined on first stage of clinical trial subcutaneously BCD-131
Number of Participants With Adverse Events and Serious Adverse Events	0 Participants	1 Participants	2 Participants	2 Participants	0 Participants	0 Participants	2 Participants	4 Participants	4 Participants	4 Participants	5 Participants

SECONDARY outcome

Timeframe: from the first administartion of the drug up to the end of follow up period (28 days after the last dose of the drug)

Incidence of administration site reactions

Outcome measures

Outcome measures
Measure	BCD-131, 0.05 mcg/kg Subcutaneously n=3 Participants Healthy volunteers received BCD-131 in a dose 0.05 mcg/kg subcutaneously BCD-131	BCD-131, 0.15 mcg/kg Subcutaneously n=3 Participants Healthy volunteers received BCD-131 in a dose 0.15 mcg/kg subcutaneously BCD-131	BCD-131, 0.40 mcg/kg Subcutaneously n=3 Participants Healthy volunteers received BCD-131 in a dose 0.40 mcg/kg subcutaneously BCD-131	BCD-131, 1.05 mcg/kg Subcutaneously n=3 Participants Healthy volunteers received BCD-131 in a dose 1.05 mcg/kg subcutaneously BCD-131	BCD-131, 1.70 mcg/kg SC n=3 Participants Healthy volunteers received BCD-131 in a dose 1.70 mcg/kg subcutaneously BCD-131	BCD-131, 2.25 mcg/kg SC n=3 Participants Healthy volunteers received BCD-131 in a dose 2.25 mcg/kg subcutaneously BCD-131	BCD-131, 4.45 mcg/kg Subcutaneously n=3 Participants Healthy volunteers received BCD-131 in a dose 4.45 mcg/kg subcutaneously BCD-131	Mircera®, 1.20 mcg/kg Subcutaneously n=6 Participants Healthy volunteers received Mircera in a dose 1.20 mcg/kg subcutaneously Mircera®	Aranesp®, 0.45 mcg/kg Subcutaneously n=6 Participants Healthy volunteers received BCD-131 in a dose 0.45 mcg/kg subcutaneously Aranesp®	BCD-131, Optimal Dose, Intravenously n=6 Participants Healthy volunteers received BCD-131 in optimal dose - 2,75 mcg/kg determined on first stage of clinical trial intravenously BCD-131	BCD-131, Optimal Dose, Subcutaneously n=6 Participants Healthy volunteers will receive BCD-131 in optimal dose - 2,75 mcg/kgdetermined on first stage of clinical trial subcutaneously BCD-131
Number of Participants With Local Reactions	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: from the first administartion of the drug up to the end of follow up period (28 days after the last dose of the drug)

Incidence of Grade 3-4 AEs and SAEs.

Outcome measures

Outcome measures
Measure	BCD-131, 0.05 mcg/kg Subcutaneously n=3 Participants Healthy volunteers received BCD-131 in a dose 0.05 mcg/kg subcutaneously BCD-131	BCD-131, 0.15 mcg/kg Subcutaneously n=3 Participants Healthy volunteers received BCD-131 in a dose 0.15 mcg/kg subcutaneously BCD-131	BCD-131, 0.40 mcg/kg Subcutaneously n=3 Participants Healthy volunteers received BCD-131 in a dose 0.40 mcg/kg subcutaneously BCD-131	BCD-131, 1.05 mcg/kg Subcutaneously n=3 Participants Healthy volunteers received BCD-131 in a dose 1.05 mcg/kg subcutaneously BCD-131	BCD-131, 1.70 mcg/kg SC n=3 Participants Healthy volunteers received BCD-131 in a dose 1.70 mcg/kg subcutaneously BCD-131	BCD-131, 2.25 mcg/kg SC n=3 Participants Healthy volunteers received BCD-131 in a dose 2.25 mcg/kg subcutaneously BCD-131	BCD-131, 4.45 mcg/kg Subcutaneously n=3 Participants Healthy volunteers received BCD-131 in a dose 4.45 mcg/kg subcutaneously BCD-131	Mircera®, 1.20 mcg/kg Subcutaneously n=6 Participants Healthy volunteers received Mircera in a dose 1.20 mcg/kg subcutaneously Mircera®	Aranesp®, 0.45 mcg/kg Subcutaneously n=6 Participants Healthy volunteers received BCD-131 in a dose 0.45 mcg/kg subcutaneously Aranesp®	BCD-131, Optimal Dose, Intravenously n=6 Participants Healthy volunteers received BCD-131 in optimal dose - 2,75 mcg/kg determined on first stage of clinical trial intravenously BCD-131	BCD-131, Optimal Dose, Subcutaneously n=6 Participants Healthy volunteers will receive BCD-131 in optimal dose - 2,75 mcg/kgdetermined on first stage of clinical trial subcutaneously BCD-131
Number of Participants With AE/SAE 3-4 Grade CTCAE	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: from the first administartion of the drug up to the end of follow up period (28 days after the last dose of the drug)

Frequency of early withdrawals due to AEs and SAEs

Outcome measures

Outcome measures
Measure	BCD-131, 0.05 mcg/kg Subcutaneously n=3 Participants Healthy volunteers received BCD-131 in a dose 0.05 mcg/kg subcutaneously BCD-131	BCD-131, 0.15 mcg/kg Subcutaneously n=3 Participants Healthy volunteers received BCD-131 in a dose 0.15 mcg/kg subcutaneously BCD-131	BCD-131, 0.40 mcg/kg Subcutaneously n=3 Participants Healthy volunteers received BCD-131 in a dose 0.40 mcg/kg subcutaneously BCD-131	BCD-131, 1.05 mcg/kg Subcutaneously n=3 Participants Healthy volunteers received BCD-131 in a dose 1.05 mcg/kg subcutaneously BCD-131	BCD-131, 1.70 mcg/kg SC n=3 Participants Healthy volunteers received BCD-131 in a dose 1.70 mcg/kg subcutaneously BCD-131	BCD-131, 2.25 mcg/kg SC n=3 Participants Healthy volunteers received BCD-131 in a dose 2.25 mcg/kg subcutaneously BCD-131	BCD-131, 4.45 mcg/kg Subcutaneously n=3 Participants Healthy volunteers received BCD-131 in a dose 4.45 mcg/kg subcutaneously BCD-131	Mircera®, 1.20 mcg/kg Subcutaneously n=6 Participants Healthy volunteers received Mircera in a dose 1.20 mcg/kg subcutaneously Mircera®	Aranesp®, 0.45 mcg/kg Subcutaneously n=6 Participants Healthy volunteers received BCD-131 in a dose 0.45 mcg/kg subcutaneously Aranesp®	BCD-131, Optimal Dose, Intravenously n=6 Participants Healthy volunteers received BCD-131 in optimal dose - 2,75 mcg/kg determined on first stage of clinical trial intravenously BCD-131	BCD-131, Optimal Dose, Subcutaneously n=6 Participants Healthy volunteers will receive BCD-131 in optimal dose - 2,75 mcg/kgdetermined on first stage of clinical trial subcutaneously BCD-131
Number of Participants With Early Withdrawal Due to AE	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 0, day 50 post-dose

Incidence of Binding antibodies to BCD-131 on Day 50 after a single injection of BCD-131