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

Not yet recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04175704

Enrollment

Registered

2019-11-25

Start date

2023-12-30

Completion date

2026-01-30

Last updated

2022-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Idiopathic Urticaria

Brief 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.

Interventions

DRUGUB-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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Contacts

Primary ContactMico Hsu, Master

mico.hsu@unitedbiopharma.com+886-3-668-4800

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026