Healthy
Conditions
Keywords
pegylated interferon beta, Volunteers
Brief summary
This is an international multicenter study of tolerability, pharmacokinetics and pharmacodynamics of drug product BCD-054 (CJSC BIOCAD, Russia), administrated intramuscular and subcutaneous, compared to Rebif® (Merck Serono S.p.A., Italy) and Avonex® (Biogen Idec Ltd, UK) in healthy volunteers. The study involves 2 stages - single ascending dose administration and multiple estimated therapeutic dose administration of BCD-054.
Sponsors
Biocad
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
InInclusion Criteria: 1. Written informed consent; 2. Male gender; 3. Age 18 - 45 years inclusive; 4. Body mass index (BMI) (18,5 - 24,99 kg/m2); 5. Healthy condition proven by the volunteer's history, global assessment and laboratory analysis results: * Absence in past medical history and at screening of clinically significant dysfunctions of circulatory, respiratory, nervous, hematopoietic, endocrine and digestive systems, liver and kidneys; * No history of cardiovascular diseases and diseases of the thyroid gland * Haematology and biochemistry tests, urinalysis and thyroid hormone analysis results are within normal limits according to standards of the study site. Screening laboratory analyses should be performed not more than 14 days before volunteer's inclusion in the study; * Hemodynamic parameters are within normal limits: systolic blood pressure - from 100 to 139 mmHg, diastolic blood pressure - from 60 to 90 mmHg, heart rate - from 50 to 90 bpm; * Absence of history of chronic infection (tuberculosis) and chronic inflammation; * Absence of HIV, hepatitis B and C virus, syphilis; * Absence of acute infections within 4 weeks before inclusion in the study; * Absence of psychiatric disorders and other conditions that can interfere with volunteer's ability to follow the study protocol, including depression; * Well-being (in volunteer's opinion) within 30 days before participation in the study; 6. Absence of history of systematic alcohol and drug abuse; 7. Ability of the volunteer, in investigator's opinion, to follow the study protocol procedures and requirements; 8. Willingness of volunteers and their sexual partners of childbearing potential to use reliable contraception methods starting from 2 weeks before inclusion into the study and until 4 weeks after receiving the last dose of the investigational products. This criterion is not applicable to patients who underwent surgical sterilization. Reliable contraceptive measures include one barrier method in combination with one of the following methods: spermicides, intrauterine device or oral contraceptives used by participant's partner; 9. Consent to avoid alcohol intake within 24 hours before and 8 days after each administration of the test or reference drugs; 10. Consent to avoid grapefruit juice (or other products containing grapefruit) intake within 72 hours before and 8 days after each administration of the study or reference drugs.
Exclusion criteria
1. Previous use of IFN-β1-containing medications at any time before inclusion; 2. History of serious allergic reactions (anaphylaxis or multiple allergy); 3. Known allergy or intolerance to interferons or any other components of study or reference drugs or pegylated proteins; 4. Major surgery within 30 days before screening; 5. Impossibility to install venous catheter for blood sampling (e.g. because of skin disorders at the sites of venipuncture); 6. Diseases or other conditions that can interfere with the investigational drugs pharmacokinetics (e.g. chronic liver, kidney, blood, circulatory system, lung or neuroendocrine diseases, including diabetes mellitus and others); 7. History of fever over 40°С 8. History of increase in aminotransferases (ALT, AST) \> 2.5 × ULN 9. History of epileptic seizures; 10. Depression and/or suicidal ideas, suicide attempts in history 11. Regular oral or parenteral use of any medications including over-the-counter drugs, vitamins and nutritional additives within less than 2 weeks before inclusion in the study; 12. Intake of medications, including over-the-counter drugs and biologically active additives that can influence hemodynamics, liver function etc. (barbiturates, omeprazole, cimetidine etc.) within less than 30 days before inclusion in the study; 13. Intake of medications that influence immune status (cytokines and their inductors, glucocorticoids etc.) within less than 30 days before inclusion in the study; 14. Vaccination within 4 weeks prior to inclusion 15. Smoking more than 10 cigarettes per day; 16. Subjects who consume more than 10 units of alcohol per week or who have history of alcohol abuse or evidence of drug/chemical abuse (one unit of alcohol equals ½ l \[500 ml\] of beer, one glass \[200 ml\] of wine or l shot glass \[50 ml\] of spirits); 17. Donation of 450 ml and more of blood or plasma within 2 months before inclusion in the study; 18. Participation in other clinical studies within less than 1 month before inclusion in the study or simultaneous participation in another clinical study; 19. Previous participation in this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUC (0-168); AUC (0-336); AUC (0-672); AUC (0-∞ ) of Interferon (IFN) Beta-1a | 0 to 168 hours; 0 to 336 hours; 0 to 672 hours respectively | 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 |
| AUC(0-last); AUC (0-∞ ) BCD-054 of Interferon (IFN) Beta-1a - 180 mcg - SC, BCD-054 - 180 mcg - IM | 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 |
| AUC (0-168); AUC (0-336); AUC (0-672);AUC (0-∞ ) of Neopterin | 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 |
| AUC(0-∞), AUC(0-last) of Neopterin | 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 |
| Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | 4 weeks | Stage 1 |
| Adverse Event (AE) and Serious Adverse Event (SAE) Incidence BCD-054 - 180 mcg - SC/IM | 4 weeks | Stage 2 BCD-054 - 180 mcg - SC/IM |
Countries
Russia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 33 |
| Rebif interferon beta 1a (Rebif) 44 mcg, SC, 3 times a week for 2 weeks | 6 |
| Avonex interferon beta 1a (Avonex) 30 mcg, IM, once a week for 2 weeks | 6 |
| BCD-054 (Multiple Doses) Pegylated interferon beta 1a (BCD-054) Multiple dose - 180 mcg, IM/SC, biweekly, 3 injections | 11 |
| Total | 56 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 0 | 2 |
Baseline characteristics
| Characteristic | BCD-054 (Single Doses) | Rebif | Avonex | BCD-054 (Multiple Doses) | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 33 Participants | 6 Participants | 6 Participants | 11 Participants | 56 Participants |
| Age, Continuous | 23 years | 23 years | 23 years | 21 years | 23 years |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 33 Participants | 6 Participants | 6 Participants | 11 Participants | 56 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 3 / 3 | 3 / 3 | 6 / 6 | 6 / 6 | 3 / 3 | 3 / 3 | 6 / 6 | 3 / 3 | 6 / 6 | 3 / 6 | 8 / 8 | 6 / 6 |
| serious Total, serious adverse events | 0 / 3 | 0 / 3 | 0 / 6 | 0 / 6 | 0 / 3 | 0 / 3 | 0 / 6 | 0 / 3 | 0 / 6 | 0 / 6 | 0 / 8 | 0 / 6 |
Outcome results
Primary
Adverse Event (AE) and Serious Adverse Event (SAE) Incidence
Stage 1
Time frame: 4 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BCD-054 - 60 mcg - SC | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Serious) Adverse Events | 0 participants |
| BCD-054 - 60 mcg - SC | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Trombocytopenia | 1 participants |
| BCD-054 - 60 mcg - SC | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Plasmatization of lymphocytes | 0 participants |
| BCD-054 - 60 mcg - SC | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Elevated erythrocyte sedimentation rate | 0 participants |
| BCD-054 - 60 mcg - SC | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Elevated AST | 0 participants |
| BCD-054 - 60 mcg - SC | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Monocytosis | 1 participants |
| BCD-054 - 60 mcg - SC | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Leucopenia | 2 participants |
| BCD-054 - 60 mcg - SC | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Other (Not Including Serious) Adverse Events | 3 participants |
| BCD-054 - 60 mcg - SC | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Vacuolation of cytoplasm of monocytes | 3 participants |
| BCD-054 - 60 mcg - SC | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Elevated gamma glutamil transferrase | 0 participants |
| BCD-054 - 60 mcg - SC | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Hyperemia of injection site | 1 participants |
| BCD-054 - 60 mcg - SC | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Lymphopenia | 0 participants |
| BCD-054 - 60 mcg - SC | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Elevated ALT | 0 participants |
| BCD-054 - 60 mcg - SC | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Fever | 0 participants |
| BCD-054 - 60 mcg - SC | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Flu-like syndrome | 1 participants |
| BCD-054 - 60 mcg - SC | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Monocytopenia | 0 participants |
| BCD-054 - 60 mcg - SC | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Neutropenia | 2 participants |
| BCD-054 - 60 mcg - IM | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Elevated erythrocyte sedimentation rate | 0 participants |
| BCD-054 - 60 mcg - IM | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Elevated ALT | 0 participants |
| BCD-054 - 60 mcg - IM | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Elevated gamma glutamil transferrase | 0 participants |
| BCD-054 - 60 mcg - IM | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Lymphopenia | 0 participants |
| BCD-054 - 60 mcg - IM | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Elevated AST | 0 participants |
| BCD-054 - 60 mcg - IM | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Leucopenia | 2 participants |
| BCD-054 - 60 mcg - IM | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Plasmatization of lymphocytes | 0 participants |
| BCD-054 - 60 mcg - IM | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Other (Not Including Serious) Adverse Events | 3 participants |
| BCD-054 - 60 mcg - IM | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Neutropenia | 2 participants |
| BCD-054 - 60 mcg - IM | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Monocytosis | 2 participants |
| BCD-054 - 60 mcg - IM | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Monocytopenia | 0 participants |
| BCD-054 - 60 mcg - IM | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Hyperemia of injection site | 0 participants |
| BCD-054 - 60 mcg - IM | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Fever | 0 participants |
| BCD-054 - 60 mcg - IM | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Flu-like syndrome | 1 participants |
| BCD-054 - 60 mcg - IM | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Trombocytopenia | 1 participants |
| BCD-054 - 60 mcg - IM | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Vacuolation of cytoplasm of monocytes | 3 participants |
| BCD-054 - 60 mcg - IM | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Serious) Adverse Events | 0 participants |
| BCD-054 - 120 mcg - SC | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Elevated ALT | 0 participants |
| BCD-054 - 120 mcg - SC | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Monocytosis | 1 participants |
| BCD-054 - 120 mcg - SC | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Lymphopenia | 0 participants |
| BCD-054 - 120 mcg - SC | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Elevated gamma glutamil transferrase | 0 participants |
| BCD-054 - 120 mcg - SC | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Neutropenia | 3 participants |
| BCD-054 - 120 mcg - SC | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Elevated AST | 0 participants |
| BCD-054 - 120 mcg - SC | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Trombocytopenia | 2 participants |
| BCD-054 - 120 mcg - SC | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Fever | 0 participants |
| BCD-054 - 120 mcg - SC | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Flu-like syndrome | 4 participants |
| BCD-054 - 120 mcg - SC | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Monocytopenia | 0 participants |
| BCD-054 - 120 mcg - SC | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Serious) Adverse Events | 0 participants |
| BCD-054 - 120 mcg - SC | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Vacuolation of cytoplasm of monocytes | 0 participants |
| BCD-054 - 120 mcg - SC | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Other (Not Including Serious) Adverse Events | 6 participants |
| BCD-054 - 120 mcg - SC | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Hyperemia of injection site | 3 participants |
| BCD-054 - 120 mcg - SC | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Plasmatization of lymphocytes | 1 participants |
| BCD-054 - 120 mcg - SC | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Elevated erythrocyte sedimentation rate | 1 participants |
| BCD-054 - 120 mcg - SC | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Leucopenia | 6 participants |
| BCD-054 - 120 mcg - IM | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Monocytosis | 2 participants |
| BCD-054 - 120 mcg - IM | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Elevated erythrocyte sedimentation rate | 2 participants |
| BCD-054 - 120 mcg - IM | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Leucopenia | 3 participants |
| BCD-054 - 120 mcg - IM | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Vacuolation of cytoplasm of monocytes | 3 participants |
| BCD-054 - 120 mcg - IM | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Elevated AST | 0 participants |
| BCD-054 - 120 mcg - IM | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Serious) Adverse Events | 0 participants |
| BCD-054 - 120 mcg - IM | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Plasmatization of lymphocytes | 0 participants |
| BCD-054 - 120 mcg - IM | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Flu-like syndrome | 6 participants |
| BCD-054 - 120 mcg - IM | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Hyperemia of injection site | 0 participants |
| BCD-054 - 120 mcg - IM | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Elevated gamma glutamil transferrase | 0 participants |
| BCD-054 - 120 mcg - IM | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Neutropenia | 2 participants |
| BCD-054 - 120 mcg - IM | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Monocytopenia | 0 participants |
| BCD-054 - 120 mcg - IM | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Elevated ALT | 1 participants |
| BCD-054 - 120 mcg - IM | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Fever | 0 participants |
| BCD-054 - 120 mcg - IM | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Other (Not Including Serious) Adverse Events | 6 participants |
| BCD-054 - 120 mcg - IM | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Lymphopenia | 0 participants |
| BCD-054 - 120 mcg - IM | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Trombocytopenia | 0 participants |
| BCD-054 - 240 mcg - SC | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Vacuolation of cytoplasm of monocytes | 0 participants |
| BCD-054 - 240 mcg - SC | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Elevated ALT | 0 participants |
| BCD-054 - 240 mcg - SC | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Serious) Adverse Events | 0 participants |
| BCD-054 - 240 mcg - SC | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Flu-like syndrome | 3 participants |
| BCD-054 - 240 mcg - SC | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Neutropenia | 2 participants |
| BCD-054 - 240 mcg - SC | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Lymphopenia | 0 participants |
| BCD-054 - 240 mcg - SC | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Elevated gamma glutamil transferrase | 0 participants |
| BCD-054 - 240 mcg - SC | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Elevated erythrocyte sedimentation rate | 0 participants |
| BCD-054 - 240 mcg - SC | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Hyperemia of injection site | 1 participants |
| BCD-054 - 240 mcg - SC | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Leucopenia | 2 participants |
| BCD-054 - 240 mcg - SC | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Plasmatization of lymphocytes | 0 participants |
| BCD-054 - 240 mcg - SC | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Other (Not Including Serious) Adverse Events | 3 participants |
| BCD-054 - 240 mcg - SC | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Monocytopenia | 0 participants |
| BCD-054 - 240 mcg - SC | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Monocytosis | 0 participants |
| BCD-054 - 240 mcg - SC | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Trombocytopenia | 2 participants |
| BCD-054 - 240 mcg - SC | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Elevated AST | 0 participants |
| BCD-054 - 240 mcg - SC | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Fever | 0 participants |
| BCD-054 - 240 mcg - IM | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Vacuolation of cytoplasm of monocytes | 0 participants |
| BCD-054 - 240 mcg - IM | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Monocytosis | 1 participants |
| BCD-054 - 240 mcg - IM | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Other (Not Including Serious) Adverse Events | 3 participants |
| BCD-054 - 240 mcg - IM | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Trombocytopenia | 0 participants |
| BCD-054 - 240 mcg - IM | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Hyperemia of injection site | 0 participants |
| BCD-054 - 240 mcg - IM | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Elevated ALT | 0 participants |
| BCD-054 - 240 mcg - IM | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Serious) Adverse Events | 0 participants |
| BCD-054 - 240 mcg - IM | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Flu-like syndrome | 3 participants |
| BCD-054 - 240 mcg - IM | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Monocytopenia | 0 participants |
| BCD-054 - 240 mcg - IM | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Neutropenia | 2 participants |
| BCD-054 - 240 mcg - IM | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Plasmatization of lymphocytes | 0 participants |
| BCD-054 - 240 mcg - IM | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Leucopenia | 2 participants |
| BCD-054 - 240 mcg - IM | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Lymphopenia | 0 participants |
| BCD-054 - 240 mcg - IM | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Elevated gamma glutamil transferrase | 0 participants |
| BCD-054 - 240 mcg - IM | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Fever | 0 participants |
| BCD-054 - 240 mcg - IM | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Elevated AST | 0 participants |
| BCD-054 - 240 mcg - IM | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Elevated erythrocyte sedimentation rate | 0 participants |
| BCD-054 - 360 mcg - SC | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Monocytopenia | 1 participants |
| BCD-054 - 360 mcg - SC | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Serious) Adverse Events | 0 participants |
| BCD-054 - 360 mcg - SC | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Elevated erythrocyte sedimentation rate | 0 participants |
| BCD-054 - 360 mcg - SC | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Leucopenia | 6 participants |
| BCD-054 - 360 mcg - SC | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Lymphopenia | 4 participants |
| BCD-054 - 360 mcg - SC | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Neutropenia | 6 participants |
| BCD-054 - 360 mcg - SC | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Fever | 2 participants |
| BCD-054 - 360 mcg - SC | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Flu-like syndrome | 4 participants |
| BCD-054 - 360 mcg - SC | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Elevated AST | 2 participants |
| BCD-054 - 360 mcg - SC | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Elevated gamma glutamil transferrase | 1 participants |
| BCD-054 - 360 mcg - SC | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Other (Not Including Serious) Adverse Events | 6 participants |
| BCD-054 - 360 mcg - SC | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Monocytosis | 0 participants |
| BCD-054 - 360 mcg - SC | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Plasmatization of lymphocytes | 0 participants |
| BCD-054 - 360 mcg - SC | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Trombocytopenia | 6 participants |
| BCD-054 - 360 mcg - SC | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Vacuolation of cytoplasm of monocytes | 0 participants |
| BCD-054 - 360 mcg - SC | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Elevated ALT | 2 participants |
| BCD-054 - 360 mcg - SC | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Hyperemia of injection site | 4 participants |
| BCD-054 - 360 mcg - IM | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Elevated erythrocyte sedimentation rate | 0 participants |
| BCD-054 - 360 mcg - IM | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Elevated AST | 0 participants |
| BCD-054 - 360 mcg - IM | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Fever | 1 participants |
| BCD-054 - 360 mcg - IM | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Hyperemia of injection site | 0 participants |
| BCD-054 - 360 mcg - IM | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Vacuolation of cytoplasm of monocytes | 1 participants |
| BCD-054 - 360 mcg - IM | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Serious) Adverse Events | 0 participants |
| BCD-054 - 360 mcg - IM | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Flu-like syndrome | 2 participants |
| BCD-054 - 360 mcg - IM | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Plasmatization of lymphocytes | 0 participants |
| BCD-054 - 360 mcg - IM | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Monocytosis | 2 participants |
| BCD-054 - 360 mcg - IM | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Monocytopenia | 0 participants |
| BCD-054 - 360 mcg - IM | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Leucopenia | 2 participants |
| BCD-054 - 360 mcg - IM | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Trombocytopenia | 2 participants |
| BCD-054 - 360 mcg - IM | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Lymphopenia | 1 participants |
| BCD-054 - 360 mcg - IM | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Neutropenia | 2 participants |
| BCD-054 - 360 mcg - IM | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Other (Not Including Serious) Adverse Events | 3 participants |
| BCD-054 - 360 mcg - IM | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Elevated gamma glutamil transferrase | 0 participants |
| BCD-054 - 360 mcg - IM | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Elevated ALT | 0 participants |
| Rebif | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Trombocytopenia | 2 participants |
| Rebif | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Other (Not Including Serious) Adverse Events | 6 participants |
| Rebif | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Serious) Adverse Events | 0 participants |
| Rebif | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Plasmatization of lymphocytes | 0 participants |
| Rebif | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Elevated gamma glutamil transferrase | 0 participants |
| Rebif | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Elevated AST | 0 participants |
| Rebif | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Vacuolation of cytoplasm of monocytes | 0 participants |
| Rebif | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Flu-like syndrome | 4 participants |
| Rebif | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Fever | 0 participants |
| Rebif | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Hyperemia of injection site | 1 participants |
| Rebif | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Elevated ALT | 0 participants |
| Rebif | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Neutropenia | 5 participants |
| Rebif | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Monocytosis | 0 participants |
| Rebif | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Lymphopenia | 0 participants |
| Rebif | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Leucopenia | 2 participants |
| Rebif | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Elevated erythrocyte sedimentation rate | 0 participants |
| Rebif | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Monocytopenia | 0 participants |
| Avonex | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Monocytopenia | 0 participants |
| Avonex | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Trombocytopenia | 0 participants |
| Avonex | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Monocytosis | 1 participants |
| Avonex | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Leucopenia | 3 participants |
| Avonex | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Lymphopenia | 0 participants |
| Avonex | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Plasmatization of lymphocytes | 0 participants |
| Avonex | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Other (Not Including Serious) Adverse Events | 3 participants |
| Avonex | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Elevated gamma glutamil transferrase | 0 participants |
| Avonex | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Vacuolation of cytoplasm of monocytes | 0 participants |
| Avonex | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Fever | 0 participants |
| Avonex | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Hyperemia of injection site | 0 participants |
| Avonex | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Flu-like syndrome | 1 participants |
| Avonex | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Elevated erythrocyte sedimentation rate | 0 participants |
| Avonex | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Elevated AST | 0 participants |
| Avonex | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Serious) Adverse Events | 0 participants |
| Avonex | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Elevated ALT | 0 participants |
| Avonex | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence | Neutropenia | 3 participants |
Primary
Adverse Event (AE) and Serious Adverse Event (SAE) Incidence BCD-054 - 180 mcg - SC/IM
Stage 2 BCD-054 - 180 mcg - SC/IM
Time frame: 4 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BCD-054 - 60 mcg - SC | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence BCD-054 - 180 mcg - SC/IM | Elevated ALT | 3 participants |
| BCD-054 - 60 mcg - SC | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence BCD-054 - 180 mcg - SC/IM | Serious Adverse Events | 0 participants |
| BCD-054 - 60 mcg - SC | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence BCD-054 - 180 mcg - SC/IM | Flu-like syndrome | 7 participants |
| BCD-054 - 60 mcg - SC | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence BCD-054 - 180 mcg - SC/IM | Other (Not Including Serious) Adverse Events | 8 participants |
| BCD-054 - 60 mcg - SC | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence BCD-054 - 180 mcg - SC/IM | Elevated AST | 3 participants |
| BCD-054 - 60 mcg - SC | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence BCD-054 - 180 mcg - SC/IM | Leucopenia | 4 participants |
| BCD-054 - 60 mcg - SC | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence BCD-054 - 180 mcg - SC/IM | Trombocytopenia | 1 participants |
| BCD-054 - 60 mcg - SC | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence BCD-054 - 180 mcg - SC/IM | Neutropenia | 5 participants |
| BCD-054 - 60 mcg - SC | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence BCD-054 - 180 mcg - SC/IM | Hyperemia of injection site | 1 participants |
| BCD-054 - 60 mcg - SC | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence BCD-054 - 180 mcg - SC/IM | Elevated creatinine | 0 participants |
| BCD-054 - 60 mcg - IM | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence BCD-054 - 180 mcg - SC/IM | Hyperemia of injection site | 0 participants |
| BCD-054 - 60 mcg - IM | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence BCD-054 - 180 mcg - SC/IM | Trombocytopenia | 3 participants |
| BCD-054 - 60 mcg - IM | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence BCD-054 - 180 mcg - SC/IM | Flu-like syndrome | 4 participants |
| BCD-054 - 60 mcg - IM | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence BCD-054 - 180 mcg - SC/IM | Elevated ALT | 2 participants |
| BCD-054 - 60 mcg - IM | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence BCD-054 - 180 mcg - SC/IM | Elevated AST | 2 participants |
| BCD-054 - 60 mcg - IM | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence BCD-054 - 180 mcg - SC/IM | Elevated creatinine | 1 participants |
| BCD-054 - 60 mcg - IM | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence BCD-054 - 180 mcg - SC/IM | Serious Adverse Events | 0 participants |
| BCD-054 - 60 mcg - IM | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence BCD-054 - 180 mcg - SC/IM | Other (Not Including Serious) Adverse Events | 6 participants |
| BCD-054 - 60 mcg - IM | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence BCD-054 - 180 mcg - SC/IM | Leucopenia | 6 participants |
| BCD-054 - 60 mcg - IM | Adverse Event (AE) and Serious Adverse Event (SAE) Incidence BCD-054 - 180 mcg - SC/IM | Neutropenia | 5 participants |
Primary
AUC (0-168); AUC (0-336); AUC (0-672); AUC (0-∞ ) of Interferon (IFN) Beta-1a
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
Time frame: 0 to 168 hours; 0 to 336 hours; 0 to 672 hours respectively
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| BCD-054 - 60 mcg - SC | AUC (0-168); AUC (0-336); AUC (0-672); AUC (0-∞ ) of Interferon (IFN) Beta-1a | AUC (0-336) | 44569 (pg/ml)*hour |
| BCD-054 - 60 mcg - SC | AUC (0-168); AUC (0-336); AUC (0-672); AUC (0-∞ ) of Interferon (IFN) Beta-1a | AUC (0-672) | 44569 (pg/ml)*hour |
| BCD-054 - 60 mcg - SC | AUC (0-168); AUC (0-336); AUC (0-672); AUC (0-∞ ) of Interferon (IFN) Beta-1a | AUC (0-168) | 36682 (pg/ml)*hour |
| BCD-054 - 60 mcg - SC | AUC (0-168); AUC (0-336); AUC (0-672); AUC (0-∞ ) of Interferon (IFN) Beta-1a | AUC (0-∞ ) | 44569 (pg/ml)*hour |
| BCD-054 - 60 mcg - IM | AUC (0-168); AUC (0-336); AUC (0-672); AUC (0-∞ ) of Interferon (IFN) Beta-1a | AUC (0-672) | 107471 (pg/ml)*hour |
| BCD-054 - 60 mcg - IM | AUC (0-168); AUC (0-336); AUC (0-672); AUC (0-∞ ) of Interferon (IFN) Beta-1a | AUC (0-168) | 87085 (pg/ml)*hour |
| BCD-054 - 60 mcg - IM | AUC (0-168); AUC (0-336); AUC (0-672); AUC (0-∞ ) of Interferon (IFN) Beta-1a | AUC (0-336) | 103624 (pg/ml)*hour |
| BCD-054 - 60 mcg - IM | AUC (0-168); AUC (0-336); AUC (0-672); AUC (0-∞ ) of Interferon (IFN) Beta-1a | AUC (0-∞ ) | 107471 (pg/ml)*hour |
| BCD-054 - 120 mcg - SC | AUC (0-168); AUC (0-336); AUC (0-672); AUC (0-∞ ) of Interferon (IFN) Beta-1a | AUC (0-672) | 351768 (pg/ml)*hour |
| BCD-054 - 120 mcg - SC | AUC (0-168); AUC (0-336); AUC (0-672); AUC (0-∞ ) of Interferon (IFN) Beta-1a | AUC (0-∞ ) | 351768 (pg/ml)*hour |
| BCD-054 - 120 mcg - SC | AUC (0-168); AUC (0-336); AUC (0-672); AUC (0-∞ ) of Interferon (IFN) Beta-1a | AUC (0-168) | 279477 (pg/ml)*hour |
| BCD-054 - 120 mcg - SC | AUC (0-168); AUC (0-336); AUC (0-672); AUC (0-∞ ) of Interferon (IFN) Beta-1a | AUC (0-336) | 345510 (pg/ml)*hour |
| BCD-054 - 120 mcg - IM | AUC (0-168); AUC (0-336); AUC (0-672); AUC (0-∞ ) of Interferon (IFN) Beta-1a | AUC (0-168) | 176866 (pg/ml)*hour |
| BCD-054 - 120 mcg - IM | AUC (0-168); AUC (0-336); AUC (0-672); AUC (0-∞ ) of Interferon (IFN) Beta-1a | AUC (0-∞ ) | 196189 (pg/ml)*hour |
| BCD-054 - 120 mcg - IM | AUC (0-168); AUC (0-336); AUC (0-672); AUC (0-∞ ) of Interferon (IFN) Beta-1a | AUC (0-336) | 196189 (pg/ml)*hour |
| BCD-054 - 120 mcg - IM | AUC (0-168); AUC (0-336); AUC (0-672); AUC (0-∞ ) of Interferon (IFN) Beta-1a | AUC (0-672) | 196189 (pg/ml)*hour |
| BCD-054 - 240 mcg - SC | AUC (0-168); AUC (0-336); AUC (0-672); AUC (0-∞ ) of Interferon (IFN) Beta-1a | AUC (0-336) | 426025 (pg/ml)*hour |
| BCD-054 - 240 mcg - SC | AUC (0-168); AUC (0-336); AUC (0-672); AUC (0-∞ ) of Interferon (IFN) Beta-1a | AUC (0-168) | 405395 (pg/ml)*hour |
| BCD-054 - 240 mcg - SC | AUC (0-168); AUC (0-336); AUC (0-672); AUC (0-∞ ) of Interferon (IFN) Beta-1a | AUC (0-672) | 426025 (pg/ml)*hour |
| BCD-054 - 240 mcg - SC | AUC (0-168); AUC (0-336); AUC (0-672); AUC (0-∞ ) of Interferon (IFN) Beta-1a | AUC (0-∞ ) | 426025 (pg/ml)*hour |
| BCD-054 - 240 mcg - IM | AUC (0-168); AUC (0-336); AUC (0-672); AUC (0-∞ ) of Interferon (IFN) Beta-1a | AUC (0-∞ ) | 437275 (pg/ml)*hour |
| BCD-054 - 240 mcg - IM | AUC (0-168); AUC (0-336); AUC (0-672); AUC (0-∞ ) of Interferon (IFN) Beta-1a | AUC (0-336) | 437275 (pg/ml)*hour |
| BCD-054 - 240 mcg - IM | AUC (0-168); AUC (0-336); AUC (0-672); AUC (0-∞ ) of Interferon (IFN) Beta-1a | AUC (0-672) | 437275 (pg/ml)*hour |
| BCD-054 - 240 mcg - IM | AUC (0-168); AUC (0-336); AUC (0-672); AUC (0-∞ ) of Interferon (IFN) Beta-1a | AUC (0-168) | 420038 (pg/ml)*hour |
| BCD-054 - 360 mcg - SC | AUC (0-168); AUC (0-336); AUC (0-672); AUC (0-∞ ) of Interferon (IFN) Beta-1a | AUC (0-∞ ) | 1562327 (pg/ml)*hour |
| BCD-054 - 360 mcg - SC | AUC (0-168); AUC (0-336); AUC (0-672); AUC (0-∞ ) of Interferon (IFN) Beta-1a | AUC (0-672) | 1554173 (pg/ml)*hour |
| BCD-054 - 360 mcg - SC | AUC (0-168); AUC (0-336); AUC (0-672); AUC (0-∞ ) of Interferon (IFN) Beta-1a | AUC (0-336) | 1457973 (pg/ml)*hour |
| BCD-054 - 360 mcg - SC | AUC (0-168); AUC (0-336); AUC (0-672); AUC (0-∞ ) of Interferon (IFN) Beta-1a | AUC (0-168) | 1052951 (pg/ml)*hour |
| BCD-054 - 360 mcg - IM | AUC (0-168); AUC (0-336); AUC (0-672); AUC (0-∞ ) of Interferon (IFN) Beta-1a | AUC (0-336) | 407273 (pg/ml)*hour |
| BCD-054 - 360 mcg - IM | AUC (0-168); AUC (0-336); AUC (0-672); AUC (0-∞ ) of Interferon (IFN) Beta-1a | AUC (0-168) | 376277 (pg/ml)*hour |
| BCD-054 - 360 mcg - IM | AUC (0-168); AUC (0-336); AUC (0-672); AUC (0-∞ ) of Interferon (IFN) Beta-1a | AUC (0-672) | 410751 (pg/ml)*hour |
| BCD-054 - 360 mcg - IM | AUC (0-168); AUC (0-336); AUC (0-672); AUC (0-∞ ) of Interferon (IFN) Beta-1a | AUC (0-∞ ) | 410751 (pg/ml)*hour |
| Rebif | AUC (0-168); AUC (0-336); AUC (0-672); AUC (0-∞ ) of Interferon (IFN) Beta-1a | AUC (0-168) | 20423 (pg/ml)*hour |
| Rebif | AUC (0-168); AUC (0-336); AUC (0-672); AUC (0-∞ ) of Interferon (IFN) Beta-1a | AUC (0-336) | 36866 (pg/ml)*hour |
| Rebif | AUC (0-168); AUC (0-336); AUC (0-672); AUC (0-∞ ) of Interferon (IFN) Beta-1a | AUC (0-∞ ) | 54774 (pg/ml)*hour |
| Rebif | AUC (0-168); AUC (0-336); AUC (0-672); AUC (0-∞ ) of Interferon (IFN) Beta-1a | AUC (0-672) | 53715 (pg/ml)*hour |
| Avonex | AUC (0-168); AUC (0-336); AUC (0-672); AUC (0-∞ ) of Interferon (IFN) Beta-1a | AUC (0-∞ ) | 7544 (pg/ml)*hour |
| Avonex | AUC (0-168); AUC (0-336); AUC (0-672); AUC (0-∞ ) of Interferon (IFN) Beta-1a | AUC (0-336) | 6964 (pg/ml)*hour |
| Avonex | AUC (0-168); AUC (0-336); AUC (0-672); AUC (0-∞ ) of Interferon (IFN) Beta-1a | AUC (0-672) | 7544 (pg/ml)*hour |
| Avonex | AUC (0-168); AUC (0-336); AUC (0-672); AUC (0-∞ ) of Interferon (IFN) Beta-1a | AUC (0-168) | 5995 (pg/ml)*hour |
Primary
AUC (0-168); AUC (0-336); AUC (0-672);AUC (0-∞ ) of Neopterin
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
Time frame: 0 to 168 hours; 0 to 336 hours; 0 to 672 hours respectively
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| BCD-054 - 60 mcg - SC | AUC (0-168); AUC (0-336); AUC (0-672);AUC (0-∞ ) of Neopterin | AUC (0-∞ ) | 44569 nmol/L*hour |
| BCD-054 - 60 mcg - SC | AUC (0-168); AUC (0-336); AUC (0-672);AUC (0-∞ ) of Neopterin | AUC (0-168) | 36681 nmol/L*hour |
| BCD-054 - 60 mcg - SC | AUC (0-168); AUC (0-336); AUC (0-672);AUC (0-∞ ) of Neopterin | AUC (0-672) | 44569 nmol/L*hour |
| BCD-054 - 60 mcg - SC | AUC (0-168); AUC (0-336); AUC (0-672);AUC (0-∞ ) of Neopterin | AUC (0-336) | 44569 nmol/L*hour |
| BCD-054 - 60 mcg - IM | AUC (0-168); AUC (0-336); AUC (0-672);AUC (0-∞ ) of Neopterin | AUC (0-168) | 87084 nmol/L*hour |
| BCD-054 - 60 mcg - IM | AUC (0-168); AUC (0-336); AUC (0-672);AUC (0-∞ ) of Neopterin | AUC (0-336) | 103624 nmol/L*hour |
| BCD-054 - 60 mcg - IM | AUC (0-168); AUC (0-336); AUC (0-672);AUC (0-∞ ) of Neopterin | AUC (0-∞ ) | 107471 nmol/L*hour |
| BCD-054 - 60 mcg - IM | AUC (0-168); AUC (0-336); AUC (0-672);AUC (0-∞ ) of Neopterin | AUC (0-672) | 107471 nmol/L*hour |
| BCD-054 - 120 mcg - SC | AUC (0-168); AUC (0-336); AUC (0-672);AUC (0-∞ ) of Neopterin | AUC (0-336) | 345509 nmol/L*hour |
| BCD-054 - 120 mcg - SC | AUC (0-168); AUC (0-336); AUC (0-672);AUC (0-∞ ) of Neopterin | AUC (0-∞ ) | 351767 nmol/L*hour |
| BCD-054 - 120 mcg - SC | AUC (0-168); AUC (0-336); AUC (0-672);AUC (0-∞ ) of Neopterin | AUC (0-168) | 279477 nmol/L*hour |
| BCD-054 - 120 mcg - SC | AUC (0-168); AUC (0-336); AUC (0-672);AUC (0-∞ ) of Neopterin | AUC (0-672) | 351767 nmol/L*hour |
| BCD-054 - 120 mcg - IM | AUC (0-168); AUC (0-336); AUC (0-672);AUC (0-∞ ) of Neopterin | AUC (0-168) | 176865 nmol/L*hour |
| BCD-054 - 120 mcg - IM | AUC (0-168); AUC (0-336); AUC (0-672);AUC (0-∞ ) of Neopterin | AUC (0-336) | 196189 nmol/L*hour |
| BCD-054 - 120 mcg - IM | AUC (0-168); AUC (0-336); AUC (0-672);AUC (0-∞ ) of Neopterin | AUC (0-672) | 196189 nmol/L*hour |
| BCD-054 - 120 mcg - IM | AUC (0-168); AUC (0-336); AUC (0-672);AUC (0-∞ ) of Neopterin | AUC (0-∞ ) | 196189 nmol/L*hour |
| BCD-054 - 240 mcg - SC | AUC (0-168); AUC (0-336); AUC (0-672);AUC (0-∞ ) of Neopterin | AUC (0-∞ ) | 426024 nmol/L*hour |
| BCD-054 - 240 mcg - SC | AUC (0-168); AUC (0-336); AUC (0-672);AUC (0-∞ ) of Neopterin | AUC (0-672) | 426024 nmol/L*hour |
| BCD-054 - 240 mcg - SC | AUC (0-168); AUC (0-336); AUC (0-672);AUC (0-∞ ) of Neopterin | AUC (0-336) | 426024 nmol/L*hour |
| BCD-054 - 240 mcg - SC | AUC (0-168); AUC (0-336); AUC (0-672);AUC (0-∞ ) of Neopterin | AUC (0-168) | 405394 nmol/L*hour |
| BCD-054 - 240 mcg - IM | AUC (0-168); AUC (0-336); AUC (0-672);AUC (0-∞ ) of Neopterin | AUC (0-672) | 437275 nmol/L*hour |
| BCD-054 - 240 mcg - IM | AUC (0-168); AUC (0-336); AUC (0-672);AUC (0-∞ ) of Neopterin | AUC (0-∞ ) | 437275 nmol/L*hour |
| BCD-054 - 240 mcg - IM | AUC (0-168); AUC (0-336); AUC (0-672);AUC (0-∞ ) of Neopterin | AUC (0-336) | 437275 nmol/L*hour |
| BCD-054 - 240 mcg - IM | AUC (0-168); AUC (0-336); AUC (0-672);AUC (0-∞ ) of Neopterin | AUC (0-168) | 420038 nmol/L*hour |
| BCD-054 - 360 mcg - SC | AUC (0-168); AUC (0-336); AUC (0-672);AUC (0-∞ ) of Neopterin | AUC (0-672) | 1554173 nmol/L*hour |
| BCD-054 - 360 mcg - SC | AUC (0-168); AUC (0-336); AUC (0-672);AUC (0-∞ ) of Neopterin | AUC (0-∞ ) | 1562327 nmol/L*hour |
| BCD-054 - 360 mcg - SC | AUC (0-168); AUC (0-336); AUC (0-672);AUC (0-∞ ) of Neopterin | AUC (0-336) | 1457972 nmol/L*hour |
| BCD-054 - 360 mcg - SC | AUC (0-168); AUC (0-336); AUC (0-672);AUC (0-∞ ) of Neopterin | AUC (0-168) | 1052951 nmol/L*hour |
| BCD-054 - 360 mcg - IM | AUC (0-168); AUC (0-336); AUC (0-672);AUC (0-∞ ) of Neopterin | AUC (0-672) | 410750 nmol/L*hour |
| BCD-054 - 360 mcg - IM | AUC (0-168); AUC (0-336); AUC (0-672);AUC (0-∞ ) of Neopterin | AUC (0-∞ ) | 410750 nmol/L*hour |
| BCD-054 - 360 mcg - IM | AUC (0-168); AUC (0-336); AUC (0-672);AUC (0-∞ ) of Neopterin | AUC (0-336) | 407273 nmol/L*hour |
| BCD-054 - 360 mcg - IM | AUC (0-168); AUC (0-336); AUC (0-672);AUC (0-∞ ) of Neopterin | AUC (0-168) | 376277 nmol/L*hour |
| Rebif | AUC (0-168); AUC (0-336); AUC (0-672);AUC (0-∞ ) of Neopterin | AUC (0-336) | 36865 nmol/L*hour |
| Rebif | AUC (0-168); AUC (0-336); AUC (0-672);AUC (0-∞ ) of Neopterin | AUC (0-672) | 53714 nmol/L*hour |
| Rebif | AUC (0-168); AUC (0-336); AUC (0-672);AUC (0-∞ ) of Neopterin | AUC (0-168) | 20423 nmol/L*hour |
| Rebif | AUC (0-168); AUC (0-336); AUC (0-672);AUC (0-∞ ) of Neopterin | AUC (0-∞ ) | 54774 nmol/L*hour |
| Avonex | AUC (0-168); AUC (0-336); AUC (0-672);AUC (0-∞ ) of Neopterin | AUC (0-336) | 6964 nmol/L*hour |
| Avonex | AUC (0-168); AUC (0-336); AUC (0-672);AUC (0-∞ ) of Neopterin | AUC (0-672) | 7544 nmol/L*hour |
| Avonex | AUC (0-168); AUC (0-336); AUC (0-672);AUC (0-∞ ) of Neopterin | AUC (0-∞ ) | 7544 nmol/L*hour |
| Avonex | AUC (0-168); AUC (0-336); AUC (0-672);AUC (0-∞ ) of Neopterin | AUC (0-168) | 5995 nmol/L*hour |
Primary
AUC(0-∞), AUC(0-last) of Neopterin
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
Time frame: 0 to 672 hours
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| BCD-054 - 60 mcg - SC | AUC(0-∞), AUC(0-last) of Neopterin | AUC(0-∞) | 3757 (nmol/L)*hour |
| BCD-054 - 60 mcg - SC | AUC(0-∞), AUC(0-last) of Neopterin | AUC(0-last) | 3303 (nmol/L)*hour |
| BCD-054 - 60 mcg - IM | AUC(0-∞), AUC(0-last) of Neopterin | AUC(0-∞) | 3431 (nmol/L)*hour |
| BCD-054 - 60 mcg - IM | AUC(0-∞), AUC(0-last) of Neopterin | AUC(0-last) | 3242 (nmol/L)*hour |
Primary
AUC(0-last); AUC (0-∞ ) BCD-054 of Interferon (IFN) Beta-1a - 180 mcg - SC, BCD-054 - 180 mcg - IM
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
Time frame: 0 to 672 hours
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| BCD-054 - 60 mcg - SC | 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 |
| BCD-054 - 60 mcg - SC | 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 |
| BCD-054 - 60 mcg - IM | AUC(0-last); AUC (0-∞ ) BCD-054 of Interferon (IFN) Beta-1a - 180 mcg - SC, BCD-054 - 180 mcg - IM | AUC(0-last) | 210626 (pg/ml)*hour |
| BCD-054 - 60 mcg - IM | AUC(0-last); AUC (0-∞ ) BCD-054 of Interferon (IFN) Beta-1a - 180 mcg - SC, BCD-054 - 180 mcg - IM | AUC (0-∞) | 218817 (pg/ml)*hour |