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The purpose of this study is to evaluate safety, tolerability, immunogenicity, pharmacokinetics, pharmacodynamics, and efficacy of LP-003 in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LP-003 | Experimental | Single dose administration, with a dosage of 200 mg LP-003 |
|
| Placebo | Placebo Comparator | Single dose administration of LP-003 placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LP-003 200mg | Drug | Subcutaneous injection of 200 mg LP-003 |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events (AE) | From the beginning of first patient in (FPI) to the end of study up to approximately 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration-time curve from the first dose to the last measurable concentration time (AUC0-t) | From the beginning of first patient in (FPI) to the end of study up to approximately 12 months | |
| The proportion of ADA (Anti Drug Antibody) positive subjects |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai General Hospital | Shanghai | China |
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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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| Drug |
Subcutaneous injection of placebo |
|
| From the beginning of first patient in (FPI) to the end of study up to approximately 12 months |
| Serum total IgE and free IgE levels compared to baseline | From the beginning of first patient in (FPI) to the end of study up to approximately 12 months |
| D006969 |
| Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |