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The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of a single dose of UB-221 in healthy volunteers.
This is a phase I, open-label, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics,and immunogenicity of a single dose of UB-221 in healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UB-221 (0.2 mg/kg) | Experimental | Intravenous infusion |
|
| UB-221 (0.6 mg/kg) | Experimental | Intravenous infusion |
|
| UB-221 (2 mg/kg) | Experimental | Intravenous infusion |
|
| UB-221 (6 mg/kg) | Experimental | Intravenous infusion |
|
| UB-221 (10 mg/kg) | Experimental | Intravenous infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UB-221 | Biological | UB-221 (75 mg/ml) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 1.Adverse event incidence | from the baseline to day 15 after IP infusion | 15 days |
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Inclusion Criteria:
Exclusion Criteria:
• The investigator considered that the subjects were not suitable to participate in this study.
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| ID | Term |
|---|---|
| D000080223 | Chronic Urticaria |
| ID | Term |
|---|---|
| D014581 | Urticaria |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| D006969 |
| Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |