A Study of Single and Multiple Doses of LP-003 in Healthy Adult Participants
NCT ID: NCT06294288
Last Updated: 2025-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
60 participants
INTERVENTIONAL
2022-07-13
2024-03-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Cohort 1: LP-003 Dose 1 (Single)
LP-003 Dose 1 (Single)
A single dose of LP-003 (Dose 1) was administered intravenously.
Cohort 2: LP-003 Dose 2 (Single)
LP-003 Dose 2 (Single)
A single dose of LP-003 (Dose 2) was administered intravenously.
Cohort 3: LP-003 Dose 3 (Single)
LP-003 Dose 3 (Single)
A single dose of LP-003 (Dose 3) was administered intravenously.
Cohort 4: LP-003 Dose 4 (Single)
LP-003 Dose 4 (Single)
A single dose of LP-003 (Dose 4) was administered intravenously.
Cohort 5: LP-003 Dose 5 (Single)
LP-003 Dose 5 (Single)
A single dose of LP-003 (Dose 5) was administered intravenously.
Cohort 6: Placebo (Single)
Placebo (Single)
A single dose of placebo was administered intravenously.
Cohort 7: LP-003 Dose 6 (Multiple)
LP-003 Dose 6 (Multiple)
LP-003 (Dose 6) was administered multiple times subcutaneously.
Cohort 8: LP-003 Dose 7 (Multiple)
LP-003 Dose 7 (Multiple)
LP-003 (Dose 7) was administered multiple times subcutaneously.
Cohort 9: LP-003 Dose 8 (Multiple)
LP-003 Dose 8 (Multiple)
LP-003 (Dose 8) was administered multiple times subcutaneously.
Cohort 10: Placebo (Multiple)
Placebo (Multiple)
Placebo was administered multiple times subcutaneously.
Interventions
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LP-003 Dose 1 (Single)
A single dose of LP-003 (Dose 1) was administered intravenously.
LP-003 Dose 2 (Single)
A single dose of LP-003 (Dose 2) was administered intravenously.
LP-003 Dose 3 (Single)
A single dose of LP-003 (Dose 3) was administered intravenously.
LP-003 Dose 4 (Single)
A single dose of LP-003 (Dose 4) was administered intravenously.
LP-003 Dose 5 (Single)
A single dose of LP-003 (Dose 5) was administered intravenously.
Placebo (Single)
A single dose of placebo was administered intravenously.
LP-003 Dose 6 (Multiple)
LP-003 (Dose 6) was administered multiple times subcutaneously.
LP-003 Dose 7 (Multiple)
LP-003 (Dose 7) was administered multiple times subcutaneously.
LP-003 Dose 8 (Multiple)
LP-003 (Dose 8) was administered multiple times subcutaneously.
Placebo (Multiple)
Placebo was administered multiple times subcutaneously.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
50 Years
ALL
Yes
Sponsors
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Longbio Pharma
INDUSTRY
Responsible Party
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Principal Investigators
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Xueying Ding
Role: PRINCIPAL_INVESTIGATOR
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Locations
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Shanghai General Hospital
Shanghai, Shanghai Municipality, China
Countries
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Other Identifiers
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P-10-LP003-2022-01
Identifier Type: -
Identifier Source: org_study_id
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