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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

NCT06604949•Longbio Pharma

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - 50 years

Sex

ALL

Healthy Volunteers

Yes

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.

Locations (1)

Shanghai General Hospital

Shanghai, China

Key Dates

Start Date

October 23, 2024

Primary Completion Date

November 1, 2026

Completion Date

December 1, 2026

Last Updated

December 18, 2025

Enrollment

ACTUAL participants

Conditions

Chronic Spontaneous Urticaria

Interventions

LP-003 200mg

DRUG

Placebo

DRUG

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Chronic Inducible UrticariaChronic Spontaneous Urticaria

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RECRUITINGPHASE2

Phase 2b Study of EVO756 in Adults With Moderate to Severe Chronic Spontaneous Urticaria (CSU)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 18, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Study of BLU-808 in Chronic Inducible Urticaria (CIndU) and Chronic Spontaneous Urticaria (CSU)

Phase 2b Study of EVO756 in Adults With Moderate to Severe Chronic Spontaneous Urticaria (CSU)

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A Phase 3 Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria