NCT04175704

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

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: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: United BioPharma · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Chronic Idiopathic Urticaria

Interventions

Type	Name	Description
DRUG	UB-221	Name: UB-221 Active ingredient: Anti-IgE monoclonal antibody Dosage form: UB-221 drug product is presented as a sterile liquid for intravenous (IV) infusion. Each vial contains 75 mg/mL UB-221 in 1.12 mL of buffered solution

Timeline

• Start date: 2023-12-30
• Primary completion: 2024-11-30
• Completion: 2026-01-30
• First posted: 2019-11-25
• Last updated: 2022-10-03

Regulatory

• FDA-regulated drug study