Back to resultsEvaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of UB-221 as an Add-on Therapy in CSU Patients
Primary Purpose
Urticaria Chronic
Status
Completed
Phase
Phase 1
Locations
Taiwan
Study Type
Interventional
Intervention
UB-221
Sponsored by
About this trial
This is an interventional treatment trial for Urticaria Chronic focused on measuring UB-221, anti-IgE monoclonal antibody, chronic spontaneous urticaria (CSU)
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.
Sites / Locations
- Kaohsiung Chang Gung Memorial Hospital
- National Taiwan University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
UB-221 (0.2 mg/kg)
UB-221 (0.6 mg/kg)
UB-221 (2 mg/kg)
UB-221 (6 mg/kg)
UB-221 (10 mg/kg)
Arm Description
Intravenous infusion
Intravenous infusion
Intravenous infusion
Intravenous infusion
Intravenous infusion
Outcomes
Primary Outcome Measures
Adverse event incidence
from the baseline to day 15 after IP infusion
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03632291
Brief Title
Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of UB-221 as an Add-on Therapy in CSU Patients
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
April 9, 2019 (Actual)
Primary Completion Date
January 19, 2021 (Actual)
Study Completion Date
January 19, 2021 (Actual)
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
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urticaria Chronic
Keywords
UB-221, anti-IgE monoclonal antibody, chronic spontaneous urticaria (CSU)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
UB-221 (0.2 mg/kg)
Arm Type
Experimental
Arm Description
Intravenous infusion
Arm Title
UB-221 (0.6 mg/kg)
Arm Type
Experimental
Arm Description
Intravenous infusion
Arm Title
UB-221 (2 mg/kg)
Arm Type
Experimental
Arm Description
Intravenous infusion
Arm Title
UB-221 (6 mg/kg)
Arm Type
Experimental
Arm Description
Intravenous infusion
Arm Title
UB-221 (10 mg/kg)
Arm Type
Experimental
Arm Description
Intravenous infusion
Intervention Type
Biological
Intervention Name(s)
UB-221
Intervention Description
UB-221 (75 mg/ml)
Primary Outcome Measure Information:
Title
Adverse event incidence
Description
from the baseline to day 15 after IP infusion
Time Frame
15 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Kaohsiung Chang Gung Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
83301
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of UB-221 as an Add-on Therapy in CSU Patients
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