Trials / Completed
CompletedNCT04027803
Comparative Study of Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of Single Intravenous Doses of BCD-148 and Soliris®
A Double-blind, Randomized Clinical Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of Single Intravenous Doses of BCD-148 (JSC BIOCAD, Russia) and Soliris® in Healthy Volunteers
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 78 (actual)
- Sponsor
- Biocad · Industry
- Sex
- Male
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
Summary
A Double-blind, Randomized Clinical Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of Single Intravenous Doses of BCD-148 (JSC BIOCAD, Russia) and Soliris® in Healthy Volunteers
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | BCD-148 | single intravenous infusion of BCD-148 (900 mg) |
| BIOLOGICAL | Soliris | single intravenous infusion of Soliris (900 mg) |
Timeline
- Start date
- 2018-09-21
- Primary completion
- 2019-04-07
- Completion
- 2019-04-07
- First posted
- 2019-07-22
- Last updated
- 2020-05-15
- Results posted
- 2020-05-15
Locations
1 site across 1 country: Russia
Source: ClinicalTrials.gov record NCT04027803. Inclusion in this directory is not an endorsement.