A Study of Single Dose of LP-003 in Healthy Adult Subjects

To Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Dose of LP-003 in Healthy Adult Subjects

The purpose of this study is to evaluate safety, tolerability, immunogenicity, pharmacokinetics, pharmacodynamics, and efficacy of LP-003 in healthy subjects.

Study Overview

• Status: Active, not recruiting
• Conditions: Chronic Spontaneous Urticaria
• Intervention / Treatment: Drug: LP-003 200mg; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Shanghai General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Healthy males or females aged ≥18 and ≤ 50 years.
2. Male subjects must weigh ≥50 kg, and female subjects must weigh ≥45 kg, with a BMI between 19.0 and 28.0 kg/m² (inclusive).
3. Male subjects and their partners or female subjects must agree to use one or more non-pharmaceutical contraceptive methods (such as total abstinence, condoms, Iuds, partner ligation, etc.) during the trial period and for 6 months after the trial, and do not plan to donate sperm or eggs.
4. The subjects fully understand the purpose, nature, method and possible adverse reactions of the experiment, and voluntarily participate in the experiment and sign the informed consent.
5. The subjects were able to communicate well with the researchers and complete the study according to the protocol.

Exclusion Criteria:

1. People who are allergic to the experimental drug and any of its excipients, have a history of allergy to monoclonal antibodies, and are allergic to multiple drugs and food.
2. Patients who have been or are currently suffering from any clinically serious diseases such as circulatory system, endocrine system, nervous system, digestive system, respiratory system, urogenital system, hematology, immunology, psychiatric and metabolic abnormalities, or any other diseases that can interfere with the test results.
3. Patients who had undergone surgery within 3 months before the trial that the researchers judged would affect drug absorption, distribution, metabolism, and excretion, or had surgery within 4 weeks prior to the trial, or planned to have surgery during the study period.
4. Any history of infection within 14 days prior to administration.
5. A person who is currently infected with parasites or has traveled to an endemic area within the last 3 months or 24 weeks prior to administration.
6. Pregnant and lactating women.
7. Hepatitis B surface antigen, hepatitis C virus antibodies, human immunodeficiency virus antibodies, treponema pallidum antibodies A positive person.
8. Patients who have received any biological agent (including antibodies or derivatives such as omazumab) within 16 weeks prior to administration (or 5 half-lives, selecting the longer time period).
9. Participants who had participated in other clinical trials within 3 months prior to screening.
10. The investigator deems any condition unsuitable for study participation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LP-003; Single dose administration, with a dosage of 200 mg LP-003	Drug: LP-003 200mg; Subcutaneous injection of 200 mg LP-003
Placebo Comparator: Placebo; Single dose administration of LP-003 placebo	Drug: Placebo; Subcutaneous injection of placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of adverse events (AE)	From the beginning of first patient in (FPI) to the end of study up to approximately 12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Area under the concentration-time curve from the first dose to the last measurable concentration time (AUC0-t)	From the beginning of first patient in (FPI) to the end of study up to approximately 12 months
The proportion of ADA (Anti Drug Antibody) positive subjects	From the beginning of first patient in (FPI) to the end of study up to approximately 12 months
Serum total IgE and free IgE levels compared to baseline	From the beginning of first patient in (FPI) to the end of study up to approximately 12 months

Collaborators and Investigators

• Sponsor: Longbio Pharma
• Collaborators: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: September 14, 2024
• First Submitted That Met QC Criteria: September 17, 2024
• First Posted (Actual): September 20, 2024

Study Record Updates

• Last Update Posted (Actual): December 18, 2025
• Last Update Submitted That Met QC Criteria: December 11, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases; Urticaria; Skin Diseases, Vascular; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Chronic Urticaria
• Other Study ID Numbers: P10-LP003-07

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No