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NCT Number: NCT06604949

A Study 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

LP-003 200mg

Drug

Subcutaneous injection of 200 mg LP-003

Placebo

Drug

Subcutaneous injection of placebo

Primary outcomes

  1. Incidence of adverse events (AE)

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

Secondary outcomes

  1. Area under the concentration-time curve from the first dose to the last measurable concentration time (AUC0-t)

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

  2. The proportion of ADA (Anti Drug Antibody) positive subjects

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

  3. Serum total IgE and free IgE levels compared to baseline

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

Sponsors and collaborators

Lead sponsor

Longbio Pharma

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 20, 2024
Registry last updated
Dec 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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