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

Longbio Pharma

Status and phase

Not yet enrolling

Phase 2

Phase 1

Conditions

Chronic Spontaneous Urticaria (CSU)

Seasonal Allergic Rhinitis (SAR)

Treatments

Biological: LP-003 Dose 1 (Single)

Biological: LP-003 Dose 2 (Single)

Study type

Interventional

Funder types

Industry

Identifiers

NCT07148557

P10-LP003-09

Details and patient eligibility

About

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.

Enrollment

6 estimated patients

Sex

All

Ages

12 to 18 years old

Volunteers

Accepts Healthy Volunteers

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.