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Clinical Trial Summary

The study is to evaluate the profiles of safety, tolerability, pharmacokinetics, and pharmacodynamics of UB-221. In this study, safety profile of UB-221 and maximum tolerated dose (MTD) is to be investigated using sentinel dosing strategy. The starting dose of 0.2 mg/kg is selected based on the evaluation and comparison of various approaches including NOAEL, MABEL (minimum anticipated biological effect level), and experiences from other anti-IgE mAb drugs in development.


Clinical Trial Description

This is a phase I, randomized, single-blind, placebo-controlled, parallel group, single ascending dose study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of a single dose of UB-221 as an add-on therapy in chronic spontaneous urticaria (CSU) subjects who fail to respond to the first line H1-antihistamine treatment. Only the qualified subjects will be blinded to receive treatment. Each subject will receive only one dose of UB-221 or placebo. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04175704
Study type Interventional
Source United BioPharma
Contact Mico Hsu, Master
Phone +886-3-668-4800
Email mico.hsu@unitedbiopharma.com
Status Not yet recruiting
Phase Phase 1
Start date December 30, 2023
Completion date January 30, 2026

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