A Study of Single Dose of LP-003 in Adolescent Subjects (NCT07148557) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
A Study of Single Dose of LP-003 in Adolescent Subjects
China6 participantsStarted 2025-10-01
Plain-language 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.
Who can participate
Age range12 Years – 18 Years
SexALL
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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…
What they're measuring
1
Adverse Events (AE)
Timeframe: Observation for 196 days after administration