New biologic LP-003 takes first step in human safety trial
NCT ID NCT06294288
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested the safety and tolerability of a new biologic drug called LP-003 in 60 healthy volunteers. The drug is being developed for chronic spontaneous urticaria (long-lasting hives). The trial gave single or multiple doses of LP-003 or a placebo by IV to see how the body handles it and to check for side effects. As a Phase 1 first-in-human study, it is an early step to find a safe dose before testing in patients.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- LP-003 (a biologic drug given intravenously)
- What this could lead to
- If this early safety study succeeds, it could pave the way for a new treatment option for chronic spontaneous urticaria (long-lasting hives).
- What could go wrong
- This is a very early Phase 1 trial in only 60 healthy people, not patients. It is designed to check safety and dosing, not to prove the drug works. Many drugs fail at this stage.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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60 people
The number who actually took part.
- Started
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Jul 2022
- Finished
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Mar 2024
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 50 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Healthy males or females aged 18 through 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 omalizumab) 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Shanghai General Hospital
Shanghai, Shanghai Municipality, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.