drugset / Trial / NCT02359877
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
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2014-07
- Primary completion
- 2015-10
- Completion
- 2015-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BCD-054 | Protein / enzyme biologic | 60 ug | Intramuscular |
| Subject | BCD-054 | Protein / enzyme biologic | 120 ug | Intramuscular |
| Subject | BCD-054 | Protein / enzyme biologic | 180 ug | Intramuscular |
| Subject | BCD-054 | Protein / enzyme biologic | 240 ug | Intramuscular |
| Subject | BCD-054 | Protein / enzyme biologic | 360 ug | Intramuscular |
| Comparator | Interferon beta-1a | Protein / enzyme biologic | 30 ug | Intramuscular |
| Comparator | Interferon beta-1a | Protein / enzyme biologic | 44 ug | Subcutaneous |
Indications
No indication recorded.