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

NCT07148557 | Active Not Recruiting Phase 1

• 1 other identifier: P10-LP003-09
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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

Allergic Diseases

Outcome Measures

Primary Outcomes (1)

• Adverse Events (AE)

  Number of subjects with treatment-related Treatment Emergent Adverse Events (TEAEs).

  Observation for 196 days after administration

Secondary Outcomes (8)

• Time to peak concentration (Tmax) of LP-003

  Observation for 196 days after administration

• Maximum concentration (Cmax) of LP-003

  Observation for 196 days after administration

• Elimination half-life (t1/2) of LP-003

  Observation for 196 days after administration

• Area under the concentration-time curve (AUC0-t) of LP-003

  Observation for 196 days after administration

• Apparent clearance rate (CL/F) of LP-003

  Observation for 196 days after administration

Study Arms (2)

Cohort 1: LP-003 Dose 1 (Single)

EXPERIMENTAL

Biological: LP-003 Dose 1 (Single)

Cohort 2 : LP-003 Dose 2 (Single)

EXPERIMENTAL

Biological: LP-003 Dose 2 (Single)

Interventions

LP-003 Dose 1 (Single) BIOLOGICAL

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

Cohort 1: LP-003 Dose 1 (Single)

LP-003 Dose 2 (Single) BIOLOGICAL

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

Cohort 2 : LP-003 Dose 2 (Single)

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Longbio Pharma: lead

Study Sites (1)

The First Affiliated Hospital of Anhui Medical University

Hefei, China

Location

MeSH Terms

Interventions

Single Person

Intervention Hierarchy (Ancestors)

Marital Status; Family Characteristics; Demography; Population Characteristics; Socioeconomic Factors

Study Officials

• Huan Zhou

  The First Affiliated Hospital of Anhui Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2025
• First Posted: August 29, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

CN (1)