At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 35 enrolled
Drug / intervention
SB-240563 +1 morebiological
Likely dose
SB-240563 10mgfrom 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 Single Blind, Placebo Controlled, Parallel Group, Single Ascending Intravenous Dose Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SB-240563 (Mepolizumab) in Healthy Japanese Male Subjects.
In Brief
A Phase 1 clinical trial evaluating SB-240563 and Placebo for Asthma. Completed, enrolled 35 participants across 1 site.
Detailed Summary
SB-240563 is a fully humanized monoclonal antibody which is specific for human interleukin-5 (IL-5) and has been under development for severe refractory asthma. This study is the first study in Japanese subjects. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single dose SB-240563 administered intravenously to Japanese healthy male subjects.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesAustralia
Collaborators--
Timeline
Phase 1CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartAug 2011
First PostedNov 2011
Primary CompletionApr 2012
TodayJul 2026
First PostedNov 15, 2011
Enrollment StartAug 9, 2011
Primary CompletionApr 27, 2012
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 14.6 years ago
Interventions
SB-240563biological
10mg, 75mg, 250mg and 750mg IV, single dose on Day 1
Placeboother
Saline IV, single dose at Day 1