Trial Outcomes & Findings for Open Label Study of Tolerability, Pharmacokinetics and Pharmacodynamics of BCD-054 (Pegylated Interferon Beta-1a), IM and SC, Compared to Rebif® and Avonex® in Healthy Volunteers (NCT NCT02359877)

Last Updated: 2017-04-10

Results Overview

Stage 1 primary outcome measure for pharmacokinetics analysis. Area under concentration-time curve (AUC) of interferon (IFN) beta-1a from the moment of drug administration up to 168, 336, 648 hours respectively

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

60 participants

Primary outcome timeframe

0 to 168 hours; 0 to 336 hours; 0 to 672 hours respectively

Results posted on

2017-04-10

Participant Flow

Participant milestones

Participant milestones
Measure	BCD-054 (Single Doses) Pegylated interferon beta 1a (BCD-054) Single doses - 60 mcg, IM/SC; or 120 mcg, IM/SC; or 240 mcg, IM/SC; or 360 mcg, IM/SC	Rebif interferon beta 1a (Rebif) 44 mcg, SC, 3 times a week for 2 weeks	Avonex interferon beta 1a (Avonex) 30 mcg, IM, once a week for 2 weeks	BCD-054 (Multiple Dose) Pegylated interferon beta 1a (BCD-054) Multiple dose - 180 mcg, IM/SC, biweekly, 3 injections
Overall Study STARTED	34	6	6	14
Overall Study COMPLETED	33	6	6	11
Overall Study NOT COMPLETED	1	0	0	3

Reasons for withdrawal

Reasons for withdrawal
Measure	BCD-054 (Single Doses) Pegylated interferon beta 1a (BCD-054) Single doses - 60 mcg, IM/SC; or 120 mcg, IM/SC; or 240 mcg, IM/SC; or 360 mcg, IM/SC	Rebif interferon beta 1a (Rebif) 44 mcg, SC, 3 times a week for 2 weeks	Avonex interferon beta 1a (Avonex) 30 mcg, IM, once a week for 2 weeks	BCD-054 (Multiple Dose) Pegylated interferon beta 1a (BCD-054) Multiple dose - 180 mcg, IM/SC, biweekly, 3 injections
Overall Study Withdrawal by Subject	1	0	0	2
Overall Study Adverse Event	0	0	0	1

Baseline Characteristics

Open Label Study of Tolerability, Pharmacokinetics and Pharmacodynamics of BCD-054 (Pegylated Interferon Beta-1a), IM and SC, Compared to Rebif® and Avonex® in Healthy Volunteers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	BCD-054 (Single Doses) n=33 Participants Pegylated interferon beta 1a (BCD-054) Single doses - 60 mcg, IM/SC; or 120 mcg, IM/SC; or 240 mcg, IM/SC; or 360 mcg, IM/SC	Rebif n=6 Participants interferon beta 1a (Rebif) 44 mcg, SC, 3 times a week for 2 weeks	Avonex n=6 Participants interferon beta 1a (Avonex) 30 mcg, IM, once a week for 2 weeks	BCD-054 (Multiple Doses) n=11 Participants Pegylated interferon beta 1a (BCD-054) Multiple dose - 180 mcg, IM/SC, biweekly, 3 injections	Total n=56 Participants Total of all reporting groups
Age, Categorical <=18 years	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
Age, Categorical Between 18 and 65 years	33 Participants n=5 Participants	6 Participants n=7 Participants	6 Participants n=5 Participants	11 Participants n=4 Participants	56 Participants n=21 Participants
Age, Categorical >=65 years	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
Age, Continuous	23 years n=5 Participants	23 years n=7 Participants	23 years n=5 Participants	21 years n=4 Participants	23 years n=21 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
Sex: Female, Male Male	33 Participants n=5 Participants	6 Participants n=7 Participants	6 Participants n=5 Participants	11 Participants n=4 Participants	56 Participants n=21 Participants

PRIMARY outcome

Timeframe: 0 to 168 hours; 0 to 336 hours; 0 to 672 hours respectively

Outcome measures

Outcome measures
Measure	BCD-054 - 60 mcg - SC n=3 Participants Pegylated interferon beta 1a (BCD-054) Single dose - 60 mcg, subcutaneously	BCD-054 - 60 mcg - IM n=3 Participants Pegylated interferon beta 1a (BCD-054) Single dose - 60 mcg, intramuscular injection	BCD-054 - 120 mcg - SC n=6 Participants Pegylated interferon beta 1a (BCD-054) Single dose - 120 mcg, subcutaneously	BCD-054 - 120 mcg - IM n=6 Participants Pegylated interferon beta 1a (BCD-054) Single dose - 120 mcg, intramuscular injection	BCD-054 - 240 mcg - SC n=3 Participants Pegylated interferon beta 1a (BCD-054) Single dose - 240 mcg, subcutaneously	BCD-054 - 240 mcg - IM n=3 Participants Pegylated interferon beta 1a (BCD-054) Single dose - 240 mcg, intramuscular injection	BCD-054 - 360 mcg - SC n=6 Participants Pegylated interferon beta 1a (BCD-054) Single dose - 360 mcg, subcutaneously	BCD-054 - 360 mcg - IM n=3 Participants Pegylated interferon beta 1a (BCD-054) Single dose - 360 mcg, intramuscular injection	Rebif n=6 Participants interferon beta 1a (Rebif) 44 mcg, SC, 3 times a week for 2 weeks	Avonex n=6 Participants interferon beta 1a (Avonex) 30 mcg, IM, once a week for 2 weeks
AUC (0-168); AUC (0-336); AUC (0-672); AUC (0-∞ ) of Interferon (IFN) Beta-1a AUC (0-168)	36682 (pg/ml)*hour Interval 20348.0 to 132888.0	87085 (pg/ml)*hour Interval 53718.0 to 133586.0	279477 (pg/ml)*hour Interval 237578.0 to 309910.0	176866 (pg/ml)*hour Interval 119715.0 to 191402.0	405395 (pg/ml)*hour Interval 130963.0 to 835348.0	420038 (pg/ml)*hour Interval 265413.0 to 692759.0	1052951 (pg/ml)*hour Interval 534763.0 to 1195047.0	376277 (pg/ml)*hour Interval 227428.0 to 522273.0	20423 (pg/ml)*hour Interval 18115.0 to 22919.0	5995 (pg/ml)*hour Interval 5139.0 to 7093.0
AUC (0-168); AUC (0-336); AUC (0-672); AUC (0-∞ ) of Interferon (IFN) Beta-1a AUC (0-336)	44569 (pg/ml)*hour Interval 24305.0 to 175568.0	103624 (pg/ml)*hour Interval 53718.0 to 162221.0	345510 (pg/ml)*hour Interval 309323.0 to 439732.0	196189 (pg/ml)*hour Interval 136976.0 to 215301.0	426025 (pg/ml)*hour Interval 149813.0 to 931966.0	437275 (pg/ml)*hour Interval 288706.0 to 737144.0	1457973 (pg/ml)*hour Interval 554150.0 to 1625676.0	407273 (pg/ml)*hour Interval 243598.0 to 564684.0	36866 (pg/ml)*hour Interval 33072.0 to 51379.0	6964 (pg/ml)*hour Interval 6006.0 to 8067.0
AUC (0-168); AUC (0-336); AUC (0-672); AUC (0-∞ ) of Interferon (IFN) Beta-1a AUC (0-672)	44569 (pg/ml)*hour Interval 24305.0 to 185094.0	107471 (pg/ml)*hour Interval 53718.0 to 175510.0	351768 (pg/ml)*hour Interval 329256.0 to 457232.0	196189 (pg/ml)*hour Interval 136976.0 to 215301.0	426025 (pg/ml)*hour Interval 149813.0 to 938358.0	437275 (pg/ml)*hour Interval 288706.0 to 737144.0	1554173 (pg/ml)*hour Interval 563062.0 to 1849940.0	410751 (pg/ml)*hour Interval 247529.0 to 569632.0	53715 (pg/ml)*hour Interval 42627.0 to 78467.0	7544 (pg/ml)*hour Interval 6645.0 to 8596.0
AUC (0-168); AUC (0-336); AUC (0-672); AUC (0-∞ ) of Interferon (IFN) Beta-1a AUC (0-∞ )	44569 (pg/ml)*hour Interval 24305.0 to 185094.0	107471 (pg/ml)*hour Interval 53718.0 to 175510.0	351768 (pg/ml)*hour Interval 329256.0 to 457232.0	196189 (pg/ml)*hour Interval 136976.0 to 215301.0	426025 (pg/ml)*hour Interval 149813.0 to 938358.0	437275 (pg/ml)*hour Interval 288706.0 to 737144.0	1562327 (pg/ml)*hour Interval 563063.0 to 1872683.0	410751 (pg/ml)*hour Interval 247529.0 to 569632.0	54774 (pg/ml)*hour Interval 43128.0 to 78872.0	7544 (pg/ml)*hour Interval 6645.0 to 8707.0

PRIMARY outcome

Timeframe: 0 to 672 hours

Stage 2 primary outcome measure for pharmacokinetics analysis. Area under concentration-time curve (AUC) of interferon (IFN) beta-1a from the moment of drug administration until last quantifiable concentration

Outcome measures

Outcome measures
Measure	BCD-054 - 60 mcg - SC n=5 Participants Pegylated interferon beta 1a (BCD-054) Single dose - 60 mcg, subcutaneously	BCD-054 - 60 mcg - IM n=6 Participants Pegylated interferon beta 1a (BCD-054) Single dose - 60 mcg, intramuscular injection	BCD-054 - 120 mcg - SC Pegylated interferon beta 1a (BCD-054) Single dose - 120 mcg, subcutaneously	BCD-054 - 120 mcg - IM Pegylated interferon beta 1a (BCD-054) Single dose - 120 mcg, intramuscular injection	BCD-054 - 240 mcg - SC Pegylated interferon beta 1a (BCD-054) Single dose - 240 mcg, subcutaneously	BCD-054 - 240 mcg - IM Pegylated interferon beta 1a (BCD-054) Single dose - 240 mcg, intramuscular injection	BCD-054 - 360 mcg - SC Pegylated interferon beta 1a (BCD-054) Single dose - 360 mcg, subcutaneously	BCD-054 - 360 mcg - IM Pegylated interferon beta 1a (BCD-054) Single dose - 360 mcg, intramuscular injection	Rebif interferon beta 1a (Rebif) 44 mcg, SC, 3 times a week for 2 weeks	Avonex interferon beta 1a (Avonex) 30 mcg, IM, once a week for 2 weeks
AUC(0-last); AUC (0-∞ ) BCD-054 of Interferon (IFN) Beta-1a - 180 mcg - SC, BCD-054 - 180 mcg - IM AUC(0-last)	274888 (pg/ml)*hour Interval 228924.0 to 450286.0	210626 (pg/ml)*hour Interval 152236.0 to 383557.0	—	—	—	—	—	—	—	—
AUC(0-last); AUC (0-∞ ) BCD-054 of Interferon (IFN) Beta-1a - 180 mcg - SC, BCD-054 - 180 mcg - IM AUC (0-∞)	316204 (pg/ml)*hour Interval 245890.0 to 484802.0	218817 (pg/ml)*hour Interval 152236.0 to 383557.0	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: 0 to 168 hours; 0 to 336 hours; 0 to 672 hours respectively

Stage 1 primary outcome measure for pharmacodynamics analysis. Area under concentration-time curve (AUC) of neopterin from the moment of drug administration until 168, 336, 648 hours respectively

Outcome measures

Outcome measures
Measure	BCD-054 - 60 mcg - SC n=3 Participants Pegylated interferon beta 1a (BCD-054) Single dose - 60 mcg, subcutaneously	BCD-054 - 60 mcg - IM n=3 Participants Pegylated interferon beta 1a (BCD-054) Single dose - 60 mcg, intramuscular injection	BCD-054 - 120 mcg - SC n=6 Participants Pegylated interferon beta 1a (BCD-054) Single dose - 120 mcg, subcutaneously	BCD-054 - 120 mcg - IM n=6 Participants Pegylated interferon beta 1a (BCD-054) Single dose - 120 mcg, intramuscular injection	BCD-054 - 240 mcg - SC n=3 Participants Pegylated interferon beta 1a (BCD-054) Single dose - 240 mcg, subcutaneously	BCD-054 - 240 mcg - IM n=3 Participants Pegylated interferon beta 1a (BCD-054) Single dose - 240 mcg, intramuscular injection	BCD-054 - 360 mcg - SC n=6 Participants Pegylated interferon beta 1a (BCD-054) Single dose - 360 mcg, subcutaneously	BCD-054 - 360 mcg - IM n=3 Participants Pegylated interferon beta 1a (BCD-054) Single dose - 360 mcg, intramuscular injection	Rebif n=6 Participants interferon beta 1a (Rebif) 44 mcg, SC, 3 times a week for 2 weeks	Avonex n=6 Participants interferon beta 1a (Avonex) 30 mcg, IM, once a week for 2 weeks
AUC (0-168); AUC (0-336); AUC (0-672);AUC (0-∞ ) of Neopterin AUC (0-168)	36681 nmol/L*hour Interval 20348.0 to 132887.0	87084 nmol/L*hour Interval 53717.0 to 133585.0	279477 nmol/L*hour Interval 237578.0 to 309909.0	176865 nmol/L*hour Interval 119715.0 to 191401.0	405394 nmol/L*hour Interval 130963.0 to 835348.0	420038 nmol/L*hour Interval 265413.0 to 692758.0	1052951 nmol/L*hour Interval 534763.0 to 1195047.0	376277 nmol/L*hour Interval 227427.0 to 522273.0	20423 nmol/L*hour Interval 18115.0 to 22918.0	5995 nmol/L*hour Interval 5138.0 to 7092.0
AUC (0-168); AUC (0-336); AUC (0-672);AUC (0-∞ ) of Neopterin AUC (0-336)	44569 nmol/L*hour Interval 24304.0 to 175568.0	103624 nmol/L*hour Interval 53717.0 to 162221.0	345509 nmol/L*hour Interval 309322.0 to 439731.0	196189 nmol/L*hour Interval 136976.0 to 215301.0	426024 nmol/L*hour Interval 149812.0 to 931965.0	437275 nmol/L*hour Interval 288706.0 to 737144.0	1457972 nmol/L*hour Interval 554150.0 to 1625676.0	407273 nmol/L*hour Interval 243597.0 to 564684.0	36865 nmol/L*hour Interval 33071.0 to 51379.0	6964 nmol/L*hour Interval 6006.0 to 8067.0
AUC (0-168); AUC (0-336); AUC (0-672);AUC (0-∞ ) of Neopterin AUC (0-672)	44569 nmol/L*hour Interval 24304.0 to 185093.0	107471 nmol/L*hour Interval 53717.0 to 175510.0	351767 nmol/L*hour Interval 329256.0 to 457231.0	196189 nmol/L*hour Interval 136976.0 to 215301.0	426024 nmol/L*hour Interval 149812.0 to 938358.0	437275 nmol/L*hour Interval 288706.0 to 737144.0	1554173 nmol/L*hour Interval 563062.0 to 1849939.0	410750 nmol/L*hour Interval 247529.0 to 569632.0	53714 nmol/L*hour Interval 42626.0 to 78466.0	7544 nmol/L*hour Interval 6644.0 to 8596.0
AUC (0-168); AUC (0-336); AUC (0-672);AUC (0-∞ ) of Neopterin AUC (0-∞ )	44569 nmol/L*hour Interval 24304.0 to 185093.0	107471 nmol/L*hour Interval 53717.0 to 175510.0	351767 nmol/L*hour Interval 329256.0 to 457231.0	196189 nmol/L*hour Interval 136976.0 to 215301.0	426024 nmol/L*hour Interval 149812.0 to 938358.0	437275 nmol/L*hour Interval 288706.0 to 737144.0	1562327 nmol/L*hour Interval 563062.0 to 1872682.0	410750 nmol/L*hour Interval 247529.0 to 569632.0	54774 nmol/L*hour Interval 43127.0 to 78871.0	7544 nmol/L*hour Interval 6644.0 to 8707.0

PRIMARY outcome

Timeframe: 0 to 672 hours

Stage 2 primary outcome measure for pharmacodynamics analysis. Area under concentration-time curve (AUC) of neopterin from the moment of drug administration until last quantifiable concentration

Outcome measures

Outcome measures
Measure	BCD-054 - 60 mcg - SC n=5 Participants Pegylated interferon beta 1a (BCD-054) Single dose - 60 mcg, subcutaneously	BCD-054 - 60 mcg - IM n=6 Participants Pegylated interferon beta 1a (BCD-054) Single dose - 60 mcg, intramuscular injection	BCD-054 - 120 mcg - SC Pegylated interferon beta 1a (BCD-054) Single dose - 120 mcg, subcutaneously	BCD-054 - 120 mcg - IM Pegylated interferon beta 1a (BCD-054) Single dose - 120 mcg, intramuscular injection	BCD-054 - 240 mcg - SC Pegylated interferon beta 1a (BCD-054) Single dose - 240 mcg, subcutaneously	BCD-054 - 240 mcg - IM Pegylated interferon beta 1a (BCD-054) Single dose - 240 mcg, intramuscular injection	BCD-054 - 360 mcg - SC Pegylated interferon beta 1a (BCD-054) Single dose - 360 mcg, subcutaneously	BCD-054 - 360 mcg - IM Pegylated interferon beta 1a (BCD-054) Single dose - 360 mcg, intramuscular injection	Rebif interferon beta 1a (Rebif) 44 mcg, SC, 3 times a week for 2 weeks	Avonex interferon beta 1a (Avonex) 30 mcg, IM, once a week for 2 weeks
AUC(0-∞), AUC(0-last) of Neopterin AUC(0-∞)	3757 (nmol/L)*hour Interval 3334.0 to 4655.0	3431 (nmol/L)*hour Interval 2568.0 to 3614.0	—	—	—	—	—	—	—	—
AUC(0-∞), AUC(0-last) of Neopterin AUC(0-last)	3303 (nmol/L)*hour Interval 3118.0 to 4487.0	3242 (nmol/L)*hour Interval 2568.0 to 3612.0	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: 4 weeks

Stage 1

Outcome measures

Outcome measures
Measure	BCD-054 - 60 mcg - SC n=3 Participants Pegylated interferon beta 1a (BCD-054) Single dose - 60 mcg, subcutaneously	BCD-054 - 60 mcg - IM n=3 Participants Pegylated interferon beta 1a (BCD-054) Single dose - 60 mcg, intramuscular injection	BCD-054 - 120 mcg - SC n=6 Participants Pegylated interferon beta 1a (BCD-054) Single dose - 120 mcg, subcutaneously	BCD-054 - 120 mcg - IM n=6 Participants Pegylated interferon beta 1a (BCD-054) Single dose - 120 mcg, intramuscular injection	BCD-054 - 240 mcg - SC n=3 Participants Pegylated interferon beta 1a (BCD-054) Single dose - 240 mcg, subcutaneously	BCD-054 - 240 mcg - IM n=3 Participants Pegylated interferon beta 1a (BCD-054) Single dose - 240 mcg, intramuscular injection	BCD-054 - 360 mcg - SC n=6 Participants Pegylated interferon beta 1a (BCD-054) Single dose - 360 mcg, subcutaneously	BCD-054 - 360 mcg - IM n=3 Participants Pegylated interferon beta 1a (BCD-054) Single dose - 360 mcg, intramuscular injection	Rebif n=6 Participants interferon beta 1a (Rebif) 44 mcg, SC, 3 times a week for 2 weeks	Avonex n=6 Participants interferon beta 1a (Avonex) 30 mcg, IM, once a week for 2 weeks
Adverse Event (AE) and Serious Adverse Event (SAE) Incidence Serious) Adverse Events	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants
Adverse Event (AE) and Serious Adverse Event (SAE) Incidence Other (Not Including Serious) Adverse Events	3 participants	3 participants	6 participants	6 participants	3 participants	3 participants	6 participants	3 participants	6 participants	3 participants
Adverse Event (AE) and Serious Adverse Event (SAE) Incidence Elevated erythrocyte sedimentation rate	0 participants	0 participants	1 participants	2 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants
Adverse Event (AE) and Serious Adverse Event (SAE) Incidence Leucopenia	2 participants	2 participants	6 participants	3 participants	2 participants	2 participants	6 participants	2 participants	2 participants	3 participants
Adverse Event (AE) and Serious Adverse Event (SAE) Incidence Lymphopenia	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	4 participants	1 participants	0 participants	0 participants
Adverse Event (AE) and Serious Adverse Event (SAE) Incidence Monocytopenia	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	1 participants	0 participants	0 participants	0 participants
Adverse Event (AE) and Serious Adverse Event (SAE) Incidence Monocytosis	1 participants	2 participants	1 participants	2 participants	0 participants	1 participants	0 participants	2 participants	0 participants	1 participants
Adverse Event (AE) and Serious Adverse Event (SAE) Incidence Neutropenia	2 participants	2 participants	3 participants	2 participants	2 participants	2 participants	6 participants	2 participants	5 participants	3 participants
Adverse Event (AE) and Serious Adverse Event (SAE) Incidence Plasmatization of lymphocytes	0 participants	0 participants	1 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants
Adverse Event (AE) and Serious Adverse Event (SAE) Incidence Trombocytopenia	1 participants	1 participants	2 participants	0 participants	2 participants	0 participants	6 participants	2 participants	2 participants	0 participants
Adverse Event (AE) and Serious Adverse Event (SAE) Incidence Vacuolation of cytoplasm of monocytes	3 participants	3 participants	0 participants	3 participants	0 participants	0 participants	0 participants	1 participants	0 participants	0 participants
Adverse Event (AE) and Serious Adverse Event (SAE) Incidence Fever	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	2 participants	1 participants	0 participants	0 participants
Adverse Event (AE) and Serious Adverse Event (SAE) Incidence Flu-like syndrome	1 participants	1 participants	4 participants	6 participants	3 participants	3 participants	4 participants	2 participants	4 participants	1 participants
Adverse Event (AE) and Serious Adverse Event (SAE) Incidence Elevated ALT	0 participants	0 participants	0 participants	1 participants	0 participants	0 participants	2 participants	0 participants	0 participants	0 participants
Adverse Event (AE) and Serious Adverse Event (SAE) Incidence Elevated AST	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	2 participants	0 participants	0 participants	0 participants
Adverse Event (AE) and Serious Adverse Event (SAE) Incidence Elevated gamma glutamil transferrase	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	1 participants	0 participants	0 participants	0 participants
Adverse Event (AE) and Serious Adverse Event (SAE) Incidence Hyperemia of injection site	1 participants	0 participants	3 participants	0 participants	1 participants	0 participants	4 participants	0 participants	1 participants	0 participants

PRIMARY outcome

Timeframe: 4 weeks

Stage 2 BCD-054 - 180 mcg - SC/IM

Outcome measures

Outcome measures
Measure	BCD-054 - 60 mcg - SC n=8 Participants Pegylated interferon beta 1a (BCD-054) Single dose - 60 mcg, subcutaneously	BCD-054 - 60 mcg - IM n=6 Participants Pegylated interferon beta 1a (BCD-054) Single dose - 60 mcg, intramuscular injection	BCD-054 - 120 mcg - SC Pegylated interferon beta 1a (BCD-054) Single dose - 120 mcg, subcutaneously	BCD-054 - 120 mcg - IM Pegylated interferon beta 1a (BCD-054) Single dose - 120 mcg, intramuscular injection	BCD-054 - 240 mcg - SC Pegylated interferon beta 1a (BCD-054) Single dose - 240 mcg, subcutaneously	BCD-054 - 240 mcg - IM Pegylated interferon beta 1a (BCD-054) Single dose - 240 mcg, intramuscular injection	BCD-054 - 360 mcg - SC Pegylated interferon beta 1a (BCD-054) Single dose - 360 mcg, subcutaneously	BCD-054 - 360 mcg - IM Pegylated interferon beta 1a (BCD-054) Single dose - 360 mcg, intramuscular injection	Rebif interferon beta 1a (Rebif) 44 mcg, SC, 3 times a week for 2 weeks	Avonex interferon beta 1a (Avonex) 30 mcg, IM, once a week for 2 weeks
Adverse Event (AE) and Serious Adverse Event (SAE) Incidence BCD-054 - 180 mcg - SC/IM Serious Adverse Events	0 participants	0 participants	—	—	—	—	—	—	—	—
Adverse Event (AE) and Serious Adverse Event (SAE) Incidence BCD-054 - 180 mcg - SC/IM Other (Not Including Serious) Adverse Events	8 participants	6 participants	—	—	—	—	—	—	—	—
Adverse Event (AE) and Serious Adverse Event (SAE) Incidence BCD-054 - 180 mcg - SC/IM Leucopenia	4 participants	6 participants	—	—	—	—	—	—	—	—
Adverse Event (AE) and Serious Adverse Event (SAE) Incidence BCD-054 - 180 mcg - SC/IM Neutropenia	5 participants	5 participants	—	—	—	—	—	—	—	—
Adverse Event (AE) and Serious Adverse Event (SAE) Incidence BCD-054 - 180 mcg - SC/IM Trombocytopenia	1 participants	3 participants	—	—	—	—	—	—	—	—
Adverse Event (AE) and Serious Adverse Event (SAE) Incidence BCD-054 - 180 mcg - SC/IM Flu-like syndrome	7 participants	4 participants	—	—	—	—	—	—	—	—
Adverse Event (AE) and Serious Adverse Event (SAE) Incidence BCD-054 - 180 mcg - SC/IM Elevated ALT	3 participants	2 participants	—	—	—	—	—	—	—	—
Adverse Event (AE) and Serious Adverse Event (SAE) Incidence BCD-054 - 180 mcg - SC/IM Elevated AST	3 participants	2 participants	—	—	—	—	—	—	—	—
Adverse Event (AE) and Serious Adverse Event (SAE) Incidence BCD-054 - 180 mcg - SC/IM Elevated creatinine	0 participants	1 participants	—	—	—	—	—	—	—	—
Adverse Event (AE) and Serious Adverse Event (SAE) Incidence BCD-054 - 180 mcg - SC/IM Hyperemia of injection site	1 participants	0 participants	—	—	—	—	—	—	—	—

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	BCD-054 - 60 mcg - SC n=3 participants at risk Pegylated interferon beta 1a (BCD-054) Single dose - 60 mcg, subcutaneously	BCD-054 - 60 mcg - IM n=3 participants at risk Pegylated interferon beta 1a (BCD-054) Single dose - 60 mcg, intramuscular injection	BCD-054 - 120 mcg - SC n=6 participants at risk Pegylated interferon beta 1a (BCD-054) Single dose - 120 mcg, subcutaneously	BCD-054 - 120 mcg - IM n=6 participants at risk Pegylated interferon beta 1a (BCD-054) Single dose - 120 mcg, intramuscular injection	BCD-054 - 240 mcg - SC n=3 participants at risk Pegylated interferon beta 1a (BCD-054) Single dose - 240 mcg, subcutaneously	BCD-054 - 240 mcg - IM n=3 participants at risk Pegylated interferon beta 1a (BCD-054) Single dose - 240 mcg, intramuscular injection	BCD-054 - 360 mcg - SC n=6 participants at risk Pegylated interferon beta 1a (BCD-054) Single dose - 360 mcg, subcutaneously	BCD-054 - 360 mcg - IM n=3 participants at risk Pegylated interferon beta 1a (BCD-054) Single dose - 360 mcg, intramuscular injection	Rebif n=6 participants at risk interferon beta 1a (Rebif) 44 mcg, SC, 3 times a week for 2 weeks	Avonex n=6 participants at risk interferon beta 1a (Avonex) 30 mcg, IM, once a week for 2 weeks	BCD-054 - 180 mcg - SC n=8 participants at risk Pegylated interferon beta 1a (BCD-054) Single dose - 180 mcg, subcutaneously	BCD-054 - 180 mcg - IM n=6 participants at risk Pegylated interferon beta 1a (BCD-054) Single dose - 180 mcg, intramuscular injection
Blood and lymphatic system disorders Neutropenia	66.7% 2/3 • 29 days after injection	66.7% 2/3 • 29 days after injection	50.0% 3/6 • 29 days after injection	33.3% 2/6 • 29 days after injection	66.7% 2/3 • 29 days after injection	66.7% 2/3 • 29 days after injection	100.0% 6/6 • 29 days after injection	66.7% 2/3 • 29 days after injection	83.3% 5/6 • 29 days after injection	50.0% 3/6 • 29 days after injection	62.5% 5/8 • 29 days after injection	83.3% 5/6 • 29 days after injection
Blood and lymphatic system disorders Monocytosis	33.3% 1/3 • 29 days after injection	66.7% 2/3 • 29 days after injection	16.7% 1/6 • 29 days after injection	33.3% 2/6 • 29 days after injection	0.00% 0/3 • 29 days after injection	33.3% 1/3 • 29 days after injection	0.00% 0/6 • 29 days after injection	66.7% 2/3 • 29 days after injection	0.00% 0/6 • 29 days after injection	16.7% 1/6 • 29 days after injection	0.00% 0/8 • 29 days after injection	0.00% 0/6 • 29 days after injection
Blood and lymphatic system disorders Vacuolation of cytoplasm of monocytes	100.0% 3/3 • 29 days after injection	100.0% 3/3 • 29 days after injection	0.00% 0/6 • 29 days after injection	50.0% 3/6 • 29 days after injection	0.00% 0/3 • 29 days after injection	0.00% 0/3 • 29 days after injection	0.00% 0/6 • 29 days after injection	33.3% 1/3 • 29 days after injection	0.00% 0/6 • 29 days after injection	0.00% 0/6 • 29 days after injection	0.00% 0/8 • 29 days after injection	0.00% 0/6 • 29 days after injection
Blood and lymphatic system disorders Leucopenia	66.7% 2/3 • 29 days after injection	66.7% 2/3 • 29 days after injection	100.0% 6/6 • 29 days after injection	50.0% 3/6 • 29 days after injection	66.7% 2/3 • 29 days after injection	66.7% 2/3 • 29 days after injection	100.0% 6/6 • 29 days after injection	66.7% 2/3 • 29 days after injection	33.3% 2/6 • 29 days after injection	50.0% 3/6 • 29 days after injection	50.0% 4/8 • 29 days after injection	100.0% 6/6 • 29 days after injection
General disorders Flu-like syndrome	33.3% 1/3 • 29 days after injection	33.3% 1/3 • 29 days after injection	66.7% 4/6 • 29 days after injection	100.0% 6/6 • 29 days after injection	100.0% 3/3 • 29 days after injection	100.0% 3/3 • 29 days after injection	66.7% 4/6 • 29 days after injection	66.7% 2/3 • 29 days after injection	66.7% 4/6 • 29 days after injection	16.7% 1/6 • 29 days after injection	87.5% 7/8 • 29 days after injection	66.7% 4/6 • 29 days after injection
Skin and subcutaneous tissue disorders Hyperemia of injection site	33.3% 1/3 • 29 days after injection	0.00% 0/3 • 29 days after injection	50.0% 3/6 • 29 days after injection	0.00% 0/6 • 29 days after injection	33.3% 1/3 • 29 days after injection	0.00% 0/3 • 29 days after injection	66.7% 4/6 • 29 days after injection	0.00% 0/3 • 29 days after injection	16.7% 1/6 • 29 days after injection	0.00% 0/6 • 29 days after injection	12.5% 1/8 • 29 days after injection	0.00% 0/6 • 29 days after injection
Blood and lymphatic system disorders Trombocytopenia	33.3% 1/3 • 29 days after injection	33.3% 1/3 • 29 days after injection	33.3% 2/6 • 29 days after injection	0.00% 0/6 • 29 days after injection	66.7% 2/3 • 29 days after injection	0.00% 0/3 • 29 days after injection	100.0% 6/6 • 29 days after injection	66.7% 2/3 • 29 days after injection	33.3% 2/6 • 29 days after injection	0.00% 0/6 • 29 days after injection	12.5% 1/8 • 29 days after injection	50.0% 3/6 • 29 days after injection
Blood and lymphatic system disorders Elevated erythrocyte sedimentation rate	0.00% 0/3 • 29 days after injection	0.00% 0/3 • 29 days after injection	16.7% 1/6 • 29 days after injection	33.3% 2/6 • 29 days after injection	0.00% 0/3 • 29 days after injection	0.00% 0/3 • 29 days after injection	0.00% 0/6 • 29 days after injection	0.00% 0/3 • 29 days after injection	0.00% 0/6 • 29 days after injection	0.00% 0/6 • 29 days after injection	0.00% 0/8 • 29 days after injection	0.00% 0/6 • 29 days after injection
Blood and lymphatic system disorders Plasmatization of lymphocytes	0.00% 0/3 • 29 days after injection	0.00% 0/3 • 29 days after injection	16.7% 1/6 • 29 days after injection	0.00% 0/6 • 29 days after injection	0.00% 0/3 • 29 days after injection	0.00% 0/3 • 29 days after injection	0.00% 0/6 • 29 days after injection	0.00% 0/3 • 29 days after injection	0.00% 0/6 • 29 days after injection	0.00% 0/6 • 29 days after injection	0.00% 0/8 • 29 days after injection	0.00% 0/6 • 29 days after injection
Hepatobiliary disorders Elevated ALT	0.00% 0/3 • 29 days after injection	0.00% 0/3 • 29 days after injection	0.00% 0/6 • 29 days after injection	16.7% 1/6 • 29 days after injection	0.00% 0/3 • 29 days after injection	0.00% 0/3 • 29 days after injection	33.3% 2/6 • 29 days after injection	0.00% 0/3 • 29 days after injection	0.00% 0/6 • 29 days after injection	0.00% 0/6 • 29 days after injection	37.5% 3/8 • 29 days after injection	33.3% 2/6 • 29 days after injection
Hepatobiliary disorders Elevated AST	0.00% 0/3 • 29 days after injection	0.00% 0/3 • 29 days after injection	0.00% 0/6 • 29 days after injection	0.00% 0/6 • 29 days after injection	0.00% 0/3 • 29 days after injection	0.00% 0/3 • 29 days after injection	33.3% 2/6 • 29 days after injection	0.00% 0/3 • 29 days after injection	0.00% 0/6 • 29 days after injection	0.00% 0/6 • 29 days after injection	37.5% 3/8 • 29 days after injection	33.3% 2/6 • 29 days after injection
General disorders Fever	0.00% 0/3 • 29 days after injection	0.00% 0/3 • 29 days after injection	0.00% 0/6 • 29 days after injection	0.00% 0/6 • 29 days after injection	0.00% 0/3 • 29 days after injection	0.00% 0/3 • 29 days after injection	33.3% 2/6 • 29 days after injection	33.3% 1/3 • 29 days after injection	0.00% 0/6 • 29 days after injection	0.00% 0/6 • 29 days after injection	0.00% 0/8 • 29 days after injection	0.00% 0/6 • 29 days after injection
Blood and lymphatic system disorders Monocytopenia	0.00% 0/3 • 29 days after injection	0.00% 0/3 • 29 days after injection	0.00% 0/6 • 29 days after injection	0.00% 0/6 • 29 days after injection	0.00% 0/3 • 29 days after injection	0.00% 0/3 • 29 days after injection	16.7% 1/6 • 29 days after injection	0.00% 0/3 • 29 days after injection	0.00% 0/6 • 29 days after injection	0.00% 0/6 • 29 days after injection	0.00% 0/8 • 29 days after injection	0.00% 0/6 • 29 days after injection
Hepatobiliary disorders Elevated gamma glutamil transferrase	0.00% 0/3 • 29 days after injection	0.00% 0/3 • 29 days after injection	0.00% 0/6 • 29 days after injection	0.00% 0/6 • 29 days after injection	0.00% 0/3 • 29 days after injection	0.00% 0/3 • 29 days after injection	16.7% 1/6 • 29 days after injection	0.00% 0/3 • 29 days after injection	0.00% 0/6 • 29 days after injection	0.00% 0/6 • 29 days after injection	0.00% 0/8 • 29 days after injection	0.00% 0/6 • 29 days after injection
Blood and lymphatic system disorders Lymphopenia	0.00% 0/3 • 29 days after injection	0.00% 0/3 • 29 days after injection	0.00% 0/6 • 29 days after injection	0.00% 0/6 • 29 days after injection	0.00% 0/3 • 29 days after injection	0.00% 0/3 • 29 days after injection	66.7% 4/6 • 29 days after injection	33.3% 1/3 • 29 days after injection	0.00% 0/6 • 29 days after injection	0.00% 0/6 • 29 days after injection	0.00% 0/8 • 29 days after injection	0.00% 0/6 • 29 days after injection
Renal and urinary disorders Elevated creatinine	0.00% 0/3 • 29 days after injection	0.00% 0/3 • 29 days after injection	0.00% 0/6 • 29 days after injection	0.00% 0/6 • 29 days after injection	0.00% 0/3 • 29 days after injection	0.00% 0/3 • 29 days after injection	0.00% 0/6 • 29 days after injection	0.00% 0/3 • 29 days after injection	0.00% 0/6 • 29 days after injection	0.00% 0/6 • 29 days after injection	0.00% 0/8 • 29 days after injection	16.7% 1/6 • 29 days after injection

Additional Information

Biryulin Andrey

BIOCAD

Phone: +7812380 49 33

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place