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

Urticaria Chronic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03632291
• Other study ID #: UBP-A107-IgE
• Status: Completed
• Phase: Phase 1
• Start date: April 9, 2019
• Est. completion date: January 19, 2021

Study information

• Verified date: May 2022
• Source: United BioPharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: January 19, 2021
• Est. primary completion date: January 19, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Urticaria
• Urticaria
• Urticaria Chronic

Intervention

Biological:
• UB-221
UB-221 (75 mg/ml)

Locations

Country	Name	City	State
Taiwan	Kaohsiung Chang Gung Memorial Hospital	Kaohsiung
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
United BioPharma

Country where clinical trial is conducted

Taiwan, 

Outcome

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