At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 19 enrolled
Drug / intervention
BCD-089biological
Likely dose
Not stated in 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.
An Open-Label, Dose Escalation Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Subcutaneous Dose of BCD-089 in Healthy Volunteers
In Brief
A Phase 1 clinical trial evaluating BCD-089 for Healthy. Completed, enrolled 19 participants across 1 site.
Detailed Summary
This is an open label, phase 1, "3+3" dose escalating study of tolerability, safety, pharmacokinetics, pharmacodynamics and immunogenicity of a single subcutaneous injection of the novel monoclonal antibody against the interleukin-6 receptor - BCD-089. The study will enroll 19 healthy male volunteers.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesRussia
Collaborators--
Timeline
Phase 1CompletedFinished
2017201820192020202120222023202420252026
Enrollment StartNov 2016
First PostedApr 2017
Primary CompletionMay 2017
TodayJul 2026
First PostedApr 6, 2017
Enrollment StartNov 1, 2016
Primary CompletionMay 1, 2017
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 9.2 years ago
Interventions
BCD-089biological