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This is a single-center, open-label, phase Ib clinical study to evaluate the safety, pharmacokinetics and pharmacodynamic characteristics of LP-003 injection in adolescent subjects aged 12-18 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: LP-003 Dose 1 (Single) | Experimental |
| |
| Cohort 2 : LP-003 Dose 2 (Single) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LP-003 Dose 1 (Single) | Biological | A single dose of LP-003 (400 mg/dose) was SC |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events (AE) | Number of subjects with treatment-related Treatment Emergent Adverse Events (TEAEs). | Observation for 196 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 196 days after administration |
| Maximum concentration (Cmax) of LP-003 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Huan Zhou | The First Affiliated Hospital of Anhui Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Anhui Medical University | Hefei | China |
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| ID | Term |
|---|---|
| D012847 | Single Person |
| ID | Term |
|---|---|
| D017533 | Marital Status |
| D005191 | Family Characteristics |
| D003710 | Demography |
| D011154 | Population Characteristics |
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| LP-003 Dose 2 (Single) | Biological | A single dose of LP-003 (600 mg/dose) was SC |
|
The maximum concentration of LP-003 in the bloodstream after administration.
| Observation for 196 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 196 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 196 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 196 days after administration |
| Assessment of total immunoglobulin E (IgE) | The changes in serum total IgE levels compared to baseline at different assessment time points. | Observation for 196 days after administration |
| Assessment of free immunoglobulin E (IgE) | The changes in serum free IgE levels compared to baseline at different assessment time points. | Observation for 196 days after administration |
| Assessment of immunogenicity | The proportion of anti drug antibody (ADA) positive subjects at different detection time points. | Observation for 196 days after administration |
| D012959 |
| Socioeconomic Factors |