A Study of Single and Multiple Doses of LP-003 in Healthy Adult Participants
To Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Escalating Single and Multiple Doses of LP-003 in Healthy Volunteers
1 other identifier
interventional
60
1 country
1
Brief Summary
The purpose of this study is to evaluate safety, tolerability, immunogenicity, pharmacokinetics, pharmacodynamics, and efficacy of LP-003 in healthy volunteers. The study will be conducted in 2 parts: Part 1, the single ascending dose (SAD) is the first in human (FIH) study of LP-003 and Part 2, multiple ascending dose (MAD).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jul 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 13, 2022
CompletedFirst Submitted
Initial submission to the registry
February 20, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 4, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 4, 2024
CompletedFirst Posted
Study publicly available on registry
March 5, 2024
CompletedDecember 12, 2025
December 1, 2025
1.6 years
February 20, 2024
December 5, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Adverse events
Number of subjects with treatment-related Treatment Emergent Adverse Events (TEAEs).
Observation for 280 days after administration
Secondary Outcomes (8)
Time to peak concentration (Tmax) of LP-003
Observation for 280 days after administration
Maximum concentration (Cmax) of LP-003
Observation for 280 days after administration
Elimination half-life (t1/2) of LP-003
Observation for 280 days after administration
Area under the concentration-time curve (AUC0-t) of LP-003
Observation for 280 days after administration
Apparent clearance rate (CL/F) of LP-003
Observation for 280 days after administration
- +3 more secondary outcomes
Study Arms (10)
Cohort 1: LP-003 Dose 1 (Single)
EXPERIMENTALCohort 2: LP-003 Dose 2 (Single)
EXPERIMENTALCohort 3: LP-003 Dose 3 (Single)
EXPERIMENTALCohort 4: LP-003 Dose 4 (Single)
EXPERIMENTALCohort 5: LP-003 Dose 5 (Single)
EXPERIMENTALCohort 6: Placebo (Single)
PLACEBO COMPARATORCohort 7: LP-003 Dose 6 (Multiple)
EXPERIMENTALCohort 8: LP-003 Dose 7 (Multiple)
EXPERIMENTALCohort 9: LP-003 Dose 8 (Multiple)
EXPERIMENTALCohort 10: Placebo (Multiple)
PLACEBO COMPARATORInterventions
A single dose of LP-003 (Dose 5) was administered intravenously.
A single dose of placebo was administered intravenously.
LP-003 (Dose 7) was administered multiple times subcutaneously.
LP-003 (Dose 8) was administered multiple times subcutaneously.
Placebo was administered multiple times subcutaneously.
LP-003 (Dose 6) was administered multiple times subcutaneously.
A single dose of LP-003 (Dose 1) was administered intravenously.
A single dose of LP-003 (Dose 2) was administered intravenously.
A single dose of LP-003 (Dose 3) was administered intravenously.
A single dose of LP-003 (Dose 4) was administered intravenously.
Eligibility Criteria
You may qualify if:
- Healthy males or females aged 18 through 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.
You may not qualify if:
- 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 omalizumab) 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Longbio Pharmalead
Study Sites (1)
Shanghai General Hospital
Shanghai, Shanghai Municipality, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xueying Ding
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 20, 2024
First Posted
March 5, 2024
Study Start
July 13, 2022
Primary Completion
March 4, 2024
Study Completion
March 4, 2024
Last Updated
December 12, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share