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

Launched by LONGBIO PHARMA · Sep 17, 2024

Keywords

ClinConnect Summary

This clinical trial is designed to study a new medication called LP-003 in healthy adults. The main goal is to understand how safe it is, how well it works, and how the body processes it. The trial is focused on people who are between 18 and 50 years old and are in good health. To participate, individuals must meet certain criteria, such as being a healthy male or female within the specified age range and weight. They also need to agree to use non-drug methods of birth control during the study and for six months afterward.

Participants in this trial will receive a single dose of LP-003 and will be closely monitored for any side effects or reactions. They will also undergo tests to see how the medication affects their body. It's important to note that people with certain health conditions, allergies, or recent surgeries may not be eligible to join. This study is not currently recruiting participants, but it aims to contribute to understanding potential new treatments for chronic spontaneous urticaria, a condition that causes itchy hives without a known cause.

Gender

ALL

Eligibility criteria

• 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.