Evaluating the Safety and Tolerability and Determining the PK and PD of Single Dose UB-221 in Chronic Spontaneous Urticaria

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Chronic Idiopathic Urticaria

Intervention / Treatment
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* Drug: UB-221


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Cohort 1<br>0.2 mg/kg UB-221 or placebo | Drug: UB-221<br>* 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<br>* Other names: recombinant anti-IgE humanized IgG1 monoclonal antibody;|
| Other: Cohort2<br>0.6 mg/kg UB-221 or placebo | Drug: UB-221<br>* 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<br>* Other names: recombinant anti-IgE humanized IgG1 monoclonal antibody;|
| Other: Cohort 3<br>2 mg/kg UB-221 or placebo | Drug: UB-221<br>* 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<br>* Other names: recombinant anti-IgE humanized IgG1 monoclonal antibody;|
| Other: Cohort 4<br>6 mg/kg UB-221 or placebo | Drug: UB-221<br>* 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<br>* Other names: recombinant anti-IgE humanized IgG1 monoclonal antibody;|

What is the study measuring?
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Primary Outcome Measures

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