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

NCT06604949 | Active Not Recruiting Phase 1

• 1 other identifier: P10-LP003-07
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Spontaneous Urticaria

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events (AE)

  From the beginning of first patient in (FPI) to the end of study up to approximately 12 months

Secondary Outcomes (3)

• 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

Study Arms (2)

LP-003

EXPERIMENTAL

Single dose administration, with a dosage of 200 mg LP-003

Drug: LP-003 200mg

Placebo

PLACEBO COMPARATOR

Single dose administration of LP-003 placebo

Drug: Placebo

Interventions

LP-003 200mg DRUG

Subcutaneous injection of 200 mg LP-003

LP-003

Placebo DRUG

Subcutaneous injection of placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy males or females aged ≥18 and ≤ 50 years.
• 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).
• 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.
• 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.
• The subjects were able to communicate well with the researchers and complete the study according to the protocol.

You may not qualify if:

• 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.
• 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.
• 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.
• Any history of infection within 14 days prior to administration.
• 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.
• Pregnant and lactating women.
• Hepatitis B surface antigen, hepatitis C virus antibodies, human immunodeficiency virus antibodies, treponema pallidum antibodies A positive person.
• 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).
• Participants who had participated in other clinical trials within 3 months prior to screening.
• The investigator deems any condition unsuitable for study participation.

Sponsors & Collaborators

• Longbio Pharma: lead

Study Sites (1)

Shanghai General Hospital

Shanghai, China

Location

MeSH Terms

Conditions

Chronic Urticaria

Condition Hierarchy (Ancestors)

Urticaria; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2024
• First Posted: September 20, 2024
• Study Start: October 23, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)