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Active, not recruiting Phase 1/2

A Study of Single Dose of LP-003 in Adolescent Subjects

NCT07148557 · tracked via the Priya Life Science China tracker
Phase
Phase 1/2
Started
2025-10-01
Last updated
2026-02-17

Condition(s) studied

Allergic Diseases

Investigational drug(s) / intervention(s)

LP-003 Dose 1 (Single)LP-003 Dose 2 (Single)

LP-003 Dose 1 (Single): A single dose of LP-003 (400 mg/dose) was SC

LP-003 Dose 2 (Single): A single dose of LP-003 (600 mg/dose) was SC

Study 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.

Eligibility

Sex
ALL
Min age
12 Years
Max age
18 Years
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

  • Adverse Events (AE) — Observation for 196 days after administration
    Number of subjects with treatment-related Treatment Emergent Adverse Events (TEAEs).

Trial sites (1)

FacilityCityRegionStatus
The First Affiliated Hospital of Anhui Medical University Hefei China
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07148557 on ClinicalTrials.gov ↗ ← All trials in China