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

Phase 1

Completed

• Conditions: Urticaria Chronic
• Interventions: Biological: UB-221

• Registration Number: NCT03632291
• Lead Sponsor: United BioPharma

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.

Study Timeline

• Study First Submitted: 2018-08-13
• Study First Submitted QC: 2018-08-13
• Study First Posted: 2018-08-15
• Study Start: 2019-04-09
• Primary Completion: 2021-01-19
• Study Completion: 2021-01-19
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-12
• Last Update Posted: 2022-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
UB-221 (10 mg/kg)	UB-221	Intravenous infusion
UB-221 (0.6 mg/kg)	UB-221	Intravenous infusion
UB-221 (6 mg/kg)	UB-221	Intravenous infusion
UB-221 (0.2 mg/kg)	UB-221	Intravenous infusion
UB-221 (2 mg/kg)	UB-221	Intravenous infusion

Primary Outcome Measures

Name	Time	Method
Adverse event incidence	15 days	from the baseline to day 15 after IP infusion

Trial Locations

Locations (2)

Kaohsiung Chang Gung Memorial Hospital; 🇨🇳 Kaohsiung, Taiwan

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan