Allergic Diseases
Conditions
Brief summary
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.
Interventions
BIOLOGICALLP-003 Dose 1 (Single)
A single dose of LP-003 (400 mg/dose) was SC
BIOLOGICALLP-003 Dose 2 (Single)
A single dose of LP-003 (600 mg/dose) was SC
Sponsors
Longbio Pharma
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
Yes
Inclusion criteria
* Adolescent subjects aged ≥12 years and \<18 years, male or female. * History of allergic diseases (self-reported is acceptable), including, but not limited to, food allergies, allergic rhinitis, allergic asthma, urticaria, and atopic dermatitis. * Agreement to use effective contraception during the study and for 6 months after the end of the study. * Subject and parent or legal guardian able to understand and voluntarily sign the informed consent form, and comply with study visits and related procedures.
Exclusion criteria
* Allergic to LP-003 or its excipients. * Any serious or uncontrolled chronic disease (e.g., severe arrhythmia, ischemic heart disease, NYHA Class III/IV heart failure, severe pulmonary disease, inadequately controlled asthma, hypertension, diabetes, hypo- or hyperthyroidism) that may affect subject safety as determined by the Investigator. * History of severe allergic reactions. * Abnormal venous access, venipuncture or subcutaneous injection intolerance, history of needle or blood phobia. * Estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73m² at screening. * ALT or AST \> ULN and considered clinically significant by the Investigator. * Any other abnormal screening test result that, in the Investigator's opinion, could affect subject safety or study assessments. * Systemic corticosteroid therapy (intravenous, intramuscular, or oral) within 4 weeks prior to study drug administration. * Use of medications known to interact with epinephrine (e.g., β-blockers, ACE inhibitors, tricyclic antidepressants) within 4 weeks prior to administration. * Use of biologic products (e.g., omalizumab) within 6 months prior to administration. * Receipt vaccines within 14 days before administration or planning vaccination during the study. * Participation in other clinical trials within 3 months prior to screening or within 5 half-lives of investigational product discontinuation (whichever is longer). * Any other conditions that the Investigator considers subjects unsuitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events (AE) | Observation for 196 days after administration | Number of subjects with treatment-related Treatment Emergent Adverse Events (TEAEs). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to peak concentration (Tmax) of LP-003 | Observation for 196 days after administration | The time when the blood drug concentration reaches its peak after a single dose of medication. |
| Maximum concentration (Cmax) of LP-003 | Observation for 196 days after administration | The maximum concentration of LP-003 in the bloodstream after administration. |
| Elimination half-life (t1/2) of LP-003 | Observation for 196 days after administration | The time required for the concentration of LP-003 in the bloodstream to decrease by half. |
| Area under the concentration-time curve (AUC0-t) of LP-003 | Observation for 196 days after administration | 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. |
| Apparent clearance rate (CL/F) of LP-003 | Observation for 196 days after administration | The ratio of drug clearance to drug concentration, represents the apparent clearance of a drug after administration, adjusted for bioavailability. |
| Assessment of total immunoglobulin E (IgE) | Observation for 196 days after administration | The changes in serum total IgE levels compared to baseline at different assessment time points. |
| Assessment of free immunoglobulin E (IgE) | Observation for 196 days after administration | The changes in serum free IgE levels compared to baseline at different assessment time points. |
| Assessment of immunogenicity | Observation for 196 days after administration | The proportion of anti drug antibody (ADA) positive subjects at different detection time points. |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORHuan Zhou
The First Affiliated Hospital of Anhui Medical University
Outcome results
None listed