A Study of Single and Multiple Doses of LP-005 in Healthy Adult Participants
To Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Escalating Single and Multiple Doses of LP-005 in Healthy Volunteers
1 other identifier
interventional
68
1 country
1
Brief Summary
The purpose of this study is to evaluate safety, tolerability, immunogenicity, pharmacokinetics, pharmacodynamics, and efficacy of LP-005 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-005 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 Nov 2023
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
November 23, 2023
CompletedFirst Submitted
Initial submission to the registry
February 3, 2024
CompletedFirst Posted
Study publicly available on registry
March 5, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2024
CompletedDecember 15, 2025
October 1, 2025
9 months
February 3, 2024
December 8, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Adverse events
Number of subjects with treatment-related Treatment Emergent Adverse Events (TEAEs).
Observation for 78 days after administration
Secondary Outcomes (8)
Time to peak concentration (Tmax) of LP-005
Observation for 78 days after administration
Maximum concentration (Cmax) of LP-005
Observation for 78 days after administration
Elimination half-life (t1/2) of LP-005
Observation for 78 days after administration
Area under the concentration-time curve (AUC0-t) of LP-005
Observation for 78 days after administration
Apparent clearance rate (CL/F) of LP-005
Observation for 78 days after administration
- +3 more secondary outcomes
Study Arms (11)
Cohort 1: LP-005 Dose 1 (Single)
EXPERIMENTALCohort 2: LP-005 Dose 2 (Single)
EXPERIMENTALCohort 3: LP-005 Dose 3 (Single)
EXPERIMENTALCohort 4: LP-005 Dose 4 (Single)
EXPERIMENTALCohort 5: LP-005 Dose 5 (Single)
EXPERIMENTALCohort 6: LP-005 Dose 6 (Single)
EXPERIMENTALCohort 7: Placebo (Single)
PLACEBO COMPARATORCohort 8: LP-005 Dose 7 (Multiple)
EXPERIMENTALCohort 9: LP-005 Dose 8 (Multiple)
EXPERIMENTALCohort 10: LP-005 Dose 9 (Multiple)
EXPERIMENTALCohort 11: Placebo (Multiple)
PLACEBO COMPARATORInterventions
A single dose of LP-005 (Dose 1) was administered intravenously.
A single dose of LP-005 (Dose 2) was administered intravenously.
A single dose of LP-005 (Dose 3) was administered intravenously.
A single dose of LP-005 (Dose 4) was administered intravenously.
A single dose of LP-005 (Dose 5) was administered intravenously.
A single dose of LP-005 (Dose 6) was administered intravenously.
A single dose of placebo was administered intravenously.
LP-005 (Dose 7) was administered multiple times intravenously.
LP-005 (Dose 8) was administered multiple times intravenously.
LP-005 (Dose 9) was administered multiple times intravenously.
Placebo was administered multiple times intravenously.
Eligibility Criteria
You may qualify if:
- Healthy males or females aged 18 through 50 years
- Male subjects with a weight of ≥50 kg, female subjects with a weight of ≥45 kg, and BMI between 19.0 and 26.0 kg/m² (inclusive).
- Vaccination: Meningococcal Conjugate Vaccine, Serogroups A, C, W, Y (MPV-ACYW) meningococcal conjugate vaccine and Streptococcus pneumoniae vaccine should be given 14 days or more before randomisation.
- 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:
- Participants who are immunocompromised or have one of the following underlying diseases: anatomic absence of spleen (including sickle cell disease); congenital complement component deficiencies (complement component 3 and complement component 4).
- Any history of Neisseria gonorrhea, meningitis infection, and Guillain-Barré syndrome.
- Contraindications to meningococcal vaccination (previous medical history such as epilepsy or other brain disorders).
- Presence or suspicion of active viral, bacterial, fungal, or parasitic infection, including herpes, shingles, or cold sores, within 14 days prior to screening.
- History of unexplained recurrent infections, or use of systemic antibiotics within 90 days prior to dosing.
- Malignancy or history of malignancy, except non-melanoma skin cancer cured for more than 3 years.
- Positive HIV test (HIV-Ab), positive hepatitis B virus (HBV) test (HBsAg), positive hepatitis C virus (HCV), positive anti-syphilis helix-specific antibodies.
- Participation in a clinical trial of any other drug within 3 months prior to screening or within 5 half-lives of other clinical trial drugs (selecting the longer time period).
- Women who are pregnant, breastfeeding, or at risk of pregnancy.
- Any condition deemed unsuitable for study participation by the investigator.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Longbio Pharmalead
Study Sites (1)
Shanghai Public Health Clinical Center
Shanghai, Shanghai Municipality, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
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 3, 2024
First Posted
March 5, 2024
Study Start
November 23, 2023
Primary Completion
August 31, 2024
Study Completion
August 31, 2024
Last Updated
December 15, 2025
Record last verified: 2025-10