Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2025-12-24 @ 6:31 PM
NCT ID:
NCT07148557
Eligibility Criteria:
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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
18 Years
Study:
NCT07148557
Study Brief:
Protocol Section:
NCT07148557