Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of UB-221 as an Add-on Therapy in CSU Patients

A Phase I, Open-Label, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Dose of UB-221 as an Add-on Therapy in Patients With Chronic Spontaneous Urticaria

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03632291

Enrollment

Registered

2018-08-15

Start date

2019-04-09

Completion date

2021-01-19

Last updated

2022-05-13

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

Conditions

Urticaria Chronic

Keywords

UB-221, anti-IgE monoclonal antibody, chronic spontaneous urticaria (CSU)

Brief summary

The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of a single dose of UB-221 as an add-on therapy in patients with Chronic Spontaneous Urticaria.

Detailed description

This is a phase I, open-label, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of a single dose of UB-221 as an add-on therapy in patients with Chronic Spontaneous Urticaria.

Interventions

BIOLOGICALUB-221

UB-221 (75 mg/ml)

Study design

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Subjects with age between 20 to 65 years old (inclusive). * Subjects who are able and willing to provide the informed consent. * Male subjects with body weight of 50 kilogram (kg) or above; female subjects body weight of 45 kilogram (kg) or above. * Subjects diagnosed with chronic spontaneous urticaria (CSU).

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 is not suitable to participate in this study.

Design outcomes

Primary

Measure	Time frame	Description
Adverse event incidence	15 days	from the baseline to day 15 after IP infusion

Countries

Taiwan

Outcome results

None listed

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