At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 78 enrolled
Drug / intervention
BCD-148 +1 morebiological
Likely dose
BCD-148 900 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating BCD-148 and Soliris for Healthy Subjects. Completed, enrolled 78 participants across 1 site.
Detailed 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
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Subjects
CountriesRussia
Collaborators--
Timeline
Phase 1CompletedFinished
20192020202120222023202420252026
Enrollment StartSep 2018
Primary CompletionApr 2019
First PostedJul 2019
TodayJul 2026
First PostedJul 22, 2019
Enrollment StartSep 21, 2018
Primary CompletionApr 7, 2019
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 6.9 years ago
Interventions
BCD-148biological
single intravenous infusion of BCD-148 (900 mg)
Solirisbiological
single intravenous infusion of Soliris (900 mg)