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

NCT ID: NCT07148557

Last Updated: 2025-08-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-31
• Study Completion Date: 2026-09-30

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.

Conditions

Chronic Spontaneous Urticaria (CSU); Seasonal Allergic Rhinitis (SAR)

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort 1: LP-003 Dose 1 (Single)

Group Type: EXPERIMENTAL

LP-003 Dose 1 (Single)

Intervention Type: BIOLOGICAL

A single dose of LP-003 (400 mg/dose) was SC

Cohort 2 : LP-003 Dose 2 (Single)

Group Type: EXPERIMENTAL

LP-003 Dose 2 (Single)

Intervention Type: BIOLOGICAL

A single dose of LP-003 (600 mg/dose) was SC

Interventions

LP-003 Dose 1 (Single)

A single dose of LP-003 (400 mg/dose) was SC

Intervention Type: BIOLOGICAL

LP-003 Dose 2 (Single)

A single dose of LP-003 (600 mg/dose) was SC

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Longbio Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

P10-LP003-09

Identifier Type: -

Identifier Source: org_study_id