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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04175704
• Other study ID #: UBP-A115-IgE
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: December 30, 2023
• Est. completion date: January 30, 2026

Study information

• Verified date: September 2022
• Source: United BioPharma
• Contact: Mico Hsu, Master
• Phone: +886-3-668-4800
• Email: mico.hsu[@]unitedbiopharma.com
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 32
• Est. completion date: January 30, 2026
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subjects aged = 18 years
• Subjects who are able and willing to provide the informed consent
• Subjects diagnosed with chronic spontaneous urticaria (CSU) for more than six weeks prior to the screening visit as confirmed by investigators based on medical history.

Exclusion Criteria:

• History of significant diseases (other than CSU) or major clinical conditions by the investigator's judgment, such as auto-immune disease or psychiatric and behavioral conditions from which the investigator considers the subject not suitable to participate in this study.

Related Conditions & MeSH terms

• Chronic Idiopathic Urticaria
• Chronic Urticaria
• Urticaria

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
United BioPharma

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the safety (Adverse event (AE)/ serious adverse event (SAE)) of UB-221 in CSU patients	1.Adverse event (AE)/ serious adverse event (SAE) reporting: from treatment to EOS	99 days