Back to resultsEvaluating the Safety and Tolerability and Determining the PK and PD of Single Dose UB-221 in Chronic Spontaneous Urticaria
Primary Purpose
Chronic Idiopathic Urticaria
Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
UB-221
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Idiopathic Urticaria
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Other
Other
Other
Other
Arm Label
Cohort 1
Cohort2
Cohort 3
Cohort 4
Arm Description
0.2 mg/kg UB-221 or placebo
0.6 mg/kg UB-221 or placebo
2 mg/kg UB-221 or placebo
6 mg/kg UB-221 or placebo
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04175704
Brief Title
Evaluating the Safety and Tolerability and Determining the PK and PD of Single Dose UB-221 in Chronic Spontaneous Urticaria
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 30, 2023 (Anticipated)
Primary Completion Date
November 30, 2024 (Anticipated)
Study Completion Date
January 30, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
United BioPharma
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Idiopathic Urticaria
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cohort 1
Arm Type
Other
Arm Description
0.2 mg/kg UB-221 or placebo
Arm Title
Cohort2
Arm Type
Other
Arm Description
0.6 mg/kg UB-221 or placebo
Arm Title
Cohort 3
Arm Type
Other
Arm Description
2 mg/kg UB-221 or placebo
Arm Title
Cohort 4
Arm Type
Other
Arm Description
6 mg/kg UB-221 or placebo
Intervention Type
Drug
Intervention Name(s)
UB-221
Other Intervention Name(s)
recombinant anti-IgE humanized IgG1 monoclonal antibody
Intervention Description
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
Primary Outcome Measure Information:
Title
To evaluate the safety (Adverse event (AE)/ serious adverse event (SAE)) of UB-221 in CSU patients
Description
1.Adverse event (AE)/ serious adverse event (SAE) reporting: from treatment to EOS
Time Frame
99 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mico Hsu, Master
Phone
+886-3-668-4800
Ext
3201
Email
mico.hsu@unitedbiopharma.com
12. IPD Sharing Statement
Learn more about this trial
Evaluating the Safety and Tolerability and Determining the PK and PD of Single Dose UB-221 in Chronic Spontaneous Urticaria
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