Trials / Completed
CompletedNCT02359877
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 60 (actual)
- Sponsor
- Biocad · Industry
- Sex
- Male
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BCD-054 | |
| DRUG | Rebif | |
| DRUG | Avonex |
Timeline
- Start date
- 2014-07-01
- Primary completion
- 2015-10-01
- Completion
- 2015-12-01
- First posted
- 2015-02-10
- Last updated
- 2017-04-10
- Results posted
- 2016-12-23
Locations
1 site across 1 country: Russia
Source: ClinicalTrials.gov record NCT02359877. Inclusion in this directory is not an endorsement.