Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of UB-221 as an Add-on Therapy in CSU Patients
NCT ID: NCT03632291
Last Updated: 2022-05-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
15 participants
INTERVENTIONAL
2019-04-09
2021-01-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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UB-221 (0.2 mg/kg)
Intravenous infusion
UB-221
UB-221 (75 mg/ml)
UB-221 (0.6 mg/kg)
Intravenous infusion
UB-221
UB-221 (75 mg/ml)
UB-221 (2 mg/kg)
Intravenous infusion
UB-221
UB-221 (75 mg/ml)
UB-221 (6 mg/kg)
Intravenous infusion
UB-221
UB-221 (75 mg/ml)
UB-221 (10 mg/kg)
Intravenous infusion
UB-221
UB-221 (75 mg/ml)
Interventions
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UB-221
UB-221 (75 mg/ml)
Eligibility Criteria
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Inclusion Criteria
* 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
20 Years
75 Years
ALL
No
Sponsors
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United BioPharma
INDUSTRY
Responsible Party
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Locations
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Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Countries
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Other Identifiers
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UBP-A107-IgE
Identifier Type: -
Identifier Source: org_study_id
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