Status:
NOT_YET_RECRUITING
A Study of Single Dose of LP-003 in Adolescent Subjects
Lead Sponsor:
Longbio Pharma
Conditions:
Chronic Spontaneous Urticaria (CSU)
Seasonal Allergic Rhinitis (SAR)
Eligibility:
All Genders
12-18 years
Phase:
PHASE1
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 31 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2026
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT07148557
Start Date
August 31 2025
End Date
September 30 2026
Last Update
August 29 2025
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