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

United BioPharma2 sites in 1 country15 target enrollmentApril 9, 2019

ConditionsUrticaria Chronic

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Urticaria Chronic
Sponsor: United BioPharma
Enrollment: 15
Locations: 2
Primary Endpoint: Adverse event incidence
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 9, 2019

End Date

January 19, 2021

Last Updated

3 years ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

United BioPharma

Responsible Party

Sponsor

Eligibility Criteria

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.