At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 60 enrolled
Drug / intervention
Leucostim® +1 morebiological
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.
Single-center Open Randomized Clinical Trial to Evaluate Pharmacokinetics, Pharmacodynamics and Safety of Leucostim® (JSC "BIOCAD", Russia) Compared to Neupogen® (F. Hoffman-La Roche Ltd., Switzerland)
In Brief
A Phase 1 clinical trial evaluating Leucostim® and Neupogen® for Leucocytosis. Completed, enrolled 60 participants.
Detailed Summary
BCD-002-1 is 1 phase clinical trial to evaluate pharmacokinetics, pharmacodynamics and safety of single-injection of Leucostim® to healthy volunteers compared to Neupogen®
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLeucocytosis
Countries--
Collaborators--
Timeline
Phase 1CompletedFinished
2017201820192020202120222023202420252026
First PostedMay 2016
Enrollment StartJul 2016
Primary CompletionNov 2016
TodayJul 2026
First PostedMay 5, 2016
Enrollment StartJul 18, 2016
Primary CompletionNov 11, 2016
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 10.2 years ago
Interventions
Leucostim®biological
Leucostim® is filgrastim biosimilar.
Neupogen®biological