Conditions: Healthy
Keywords: pegylated interferon beta Volunteers
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 60
Healthy volunteers: yes

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.

Detailed description:

Arms:
arm 1: Pegylated interferon beta 1a Single doses - 60 mcg, SC/IM Single doses - 120 mcg, SC/IM Single doses - 240 mcg, SC/IM Single doses - 360 mcg, SC/IM Multiple doses - 180 mcg, SC/IM arm 2: interferon beta 1a 44 mcg, SC, 3 times a week for 2 weeks arm 3: interferon beta 1a 30 mcg, IM, once a week for 2 weeks

Interventions: intervention 1: BCD-054 intervention 2: Rebif intervention 3: Avonex
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol document: