Evaluating the Safety and Tolerability and Determining the PK and PD of Single Dose UB-221 in Chronic Spontaneous Urticaria

Chronic Idiopathic Urticaria Clinical Trial

Official title: A Phase I, Randomized, Single-Blind, Placebo-Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of UB-221 as an Add-on Therapy in Patients With Chronic Spontaneous Urticaria

Status Not yet recruiting

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. ;

Related Conditions & MeSH terms

• Chronic Idiopathic Urticaria
• Chronic Urticaria
• Urticaria

• 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