CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 180 enrolled
Drug / intervention
Benralizumab +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.

Search/NCT02968914
NCT02968914Phase 1Completed
CompareCT.gov

A Multicenter, Randomized, Open-Label, Parallel Group Phase 1 Pharmacokinetic Comparability Study of Benralizumab Administrated Using Accessorized Pre-Filled Syringe (APFS) or Autoinjector (AI) in Healthy Volunteers.

AstraZeneca·interventional·Posted Nov 21, 2016·Updated Jul 5, 2019

In Brief

A Phase 1 clinical trial evaluating Benralizumab for Asthma and Chronic Obstructive Pulmonary Disease. Completed, enrolled 180 participants across 2 sites.

Detailed Summary

An open-label, single dose Pharmacokinetic (PK) comparability study to demonstrate comparable drug exposure following Subcutaneous benralizumab administration by using accessorized pre-filled syringe (APFS) or autoinjector (AI) devices.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma, Chronic Obstructive Pulmonary Disease
CountriesGermany
CollaboratorsParexel

Timeline

Phase 1CompletedFinished
2017201820192020202120222023202420252026
First PostedNov 21, 2016
Enrollment StartJan 4, 2017
Primary CompletionJul 13, 2017
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 9.6 years ago

Interventions

Benralizumabbiological

A humanized, afucosylated, monoclonal antibody (mAb) that binds specifically to the human IL-5 receptor alpha subunit (IL-5Rα) on the target cell.

Benralizumabbiological

A humanized, afucosylated, monoclonal antibody (mAb) that binds specifically to the human IL-5 receptor alpha subunit (IL-5Rα) on the target cell.