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The purpose of this study is to evaluate safety, tolerability, immunogenicity, pharmacokinetics, pharmacodynamics, and efficacy of LP-003 in healthy volunteers. The study will be conducted in 2 parts: Part 1, the single ascending dose (SAD) is the first in human (FIH) study of LP-003 and Part 2, multiple ascending dose (MAD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: LP-003 Dose 1 (Single) | Experimental |
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| Cohort 2: LP-003 Dose 2 (Single) | Experimental |
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| Cohort 3: LP-003 Dose 3 (Single) | Experimental |
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| Cohort 4: LP-003 Dose 4 (Single) | Experimental |
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| Cohort 5: LP-003 Dose 5 (Single) | Experimental |
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| Cohort 6: Placebo (Single) | Placebo Comparator |
| |
| Cohort 7: LP-003 Dose 6 (Multiple) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LP-003 Dose 1 (Single) | Biological | A single dose of LP-003 (Dose 1) was administered intravenously. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Number of subjects with treatment-related Treatment Emergent Adverse Events (TEAEs). | Observation for 280 days after administration |
| Measure | Description | Time Frame |
|---|---|---|
| Time to peak concentration (Tmax) of LP-003 | The time when the blood drug concentration reaches its peak after a single dose of medication. | Observation for 280 days after administration |
| Maximum concentration (Cmax) of LP-003 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xueying Ding | Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai General Hospital | Shanghai | Shanghai Municipality | China |
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| Cohort 8: LP-003 Dose 7 (Multiple) | Experimental |
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| Cohort 9: LP-003 Dose 8 (Multiple) | Experimental |
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| Cohort 10: Placebo (Multiple) | Placebo Comparator |
|
| LP-003 Dose 2 (Single) | Biological | A single dose of LP-003 (Dose 2) was administered intravenously. |
|
| LP-003 Dose 3 (Single) | Biological | A single dose of LP-003 (Dose 3) was administered intravenously. |
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| LP-003 Dose 4 (Single) | Biological | A single dose of LP-003 (Dose 4) was administered intravenously. |
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| LP-003 Dose 5 (Single) | Biological | A single dose of LP-003 (Dose 5) was administered intravenously. |
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| Placebo (Single) | Biological | A single dose of placebo was administered intravenously. |
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| LP-003 Dose 6 (Multiple) | Biological | LP-003 (Dose 6) was administered multiple times subcutaneously. |
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| LP-003 Dose 7 (Multiple) | Biological | LP-003 (Dose 7) was administered multiple times subcutaneously. |
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| LP-003 Dose 8 (Multiple) | Biological | LP-003 (Dose 8) was administered multiple times subcutaneously. |
|
| Placebo (Multiple) | Biological | Placebo was administered multiple times subcutaneously. |
|
The maximum concentration of LP-003 in the bloodstream after administration.
| Observation for 280 days after administration |
| Elimination half-life (t1/2) of LP-003 | The time required for the concentration of LP-003 in the bloodstream to decrease by half. | Observation for 280 days after administration |
| Area under the concentration-time curve (AUC0-t) of LP-003 | The area under the concentration-time curve (AUC) from time zero to the last chosen time point represents the integral of the drug concentration in the bloodstream over the specified duration. | Observation for 280 days after administration |
| Apparent clearance rate (CL/F) of LP-003 | The ratio of drug clearance to drug concentration, represents the apparent clearance of a drug after administration, adjusted for bioavailability. | Observation for 280 days after administration |
| Assessment of immunogenicity | The proportion of anti drug antibody (ADA) positive subjects at different detection time points. | Observation for 280 days after administration |
| Assessment of total immunoglobulin E (IgE) | The changes in serum total immunoglobulin E (IgE) levels compared to baseline at different assessment time points. | Observation for 168 days after administration |
| Assessment of free IgE | The changes in serum free IgE levels compared to baseline at different assessment time points. | Observation for 168 days after administration |
| ID | Term |
|---|---|
| D000080223 | Chronic Urticaria |
| ID | Term |
|---|---|
| D014581 | Urticaria |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D012847 | Single Person |
| ID | Term |
|---|---|
| D017533 | Marital Status |
| D005191 | Family Characteristics |
| D003710 | Demography |
| D011154 | Population Characteristics |
| D012959 | Socioeconomic Factors |
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