At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 176 enrolled
Drug / intervention
CT-P39 +4 morebiological
Likely dose
CT-P39 150 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 Phase 1, Randomized, Double-blind, Three-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics and Safety of Three Formulations of Omalizumab (CT-P39, EU-approved Xolair, and US-licensed Xolair) in Healthy Subjects
In Brief
A Phase 1 clinical trial evaluating CT-P39, EU-approved Xolair, and 1 other intervention for Healthy. Completed, enrolled 176 participants across 2 sites.
Detailed Summary
A Phase 1, Randomized, Double-blind, Three-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics and Safety of Three Formulations of Omalizumab (CT-P39, EU-approved Xolair, and US-licensed Xolair) in Healthy Subjects
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesAustralia
Collaborators--
Timeline
Phase 1CompletedFinished
2020202120222023202420252026
First PostedJul 2019
Enrollment StartMay 2020
Primary CompletionMar 2021
Study CompletionApr 2021
TodayJul 2026
First PostedJul 12, 2019
Enrollment StartMay 28, 2020
Primary CompletionMar 27, 2021
Study CompletionApr 30, 2021
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 7.0 years ago
Interventions
CT-P39biological
150 mg/mL, Solution for injection in PFS
EU-approved Xolairbiological
150 mg/mL, Solution for injection in PFS
CT-P39biological
150 mg/mL, Solution for injection in PFS
EU-approved Xolairbiological
150 mg/mL, Solution for injection in PFS
US-licensed Xolairbiological
150 mg/mL, Solution for injection in PFS