A Study of Single and Multiple Dose Administration of LP-001 in Healthy Subjects
A Phase I Clinical Study Evaluating the Safety, Tolerability, and Pharmacokinetics of LP-001 Injection in Healthy Subjects Following Single and Multiple Doses
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-001 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-001 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 Sep 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
September 3, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 16, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 16, 2023
CompletedFirst Submitted
Initial submission to the registry
February 20, 2024
CompletedFirst Posted
Study publicly available on registry
March 5, 2024
CompletedDecember 15, 2025
December 1, 2025
12 months
February 20, 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 36 days after administration
Secondary Outcomes (9)
Time to peak concentration (Tmax) of LP-001
Observation for 36 days after administration
Maximum concentration (Cmax) of LP-001
Observation for 36 days after administration
Elimination half-life (t1/2) of LP-001
Observation for 36 days after administration
Area under the concentration-time curve (AUC0-t) of LP-001
Observation for 36 days after administration
Apparent clearance rate (CL/F) of LP-001
Observation for 36 days after administration
- +4 more secondary outcomes
Study Arms (10)
Cohort 1: LP-001 Dose 1 (Single)
EXPERIMENTALSingle dose administration of LP-001 with dose 1
Cohort 2: LP-001 Dose 2 (Single)
EXPERIMENTALSingle dose administration of LP-001 with dose 2
Cohort 3: LP-001 Dose 3 (Single)
EXPERIMENTALSingle dose administration of LP-001 with dose 3
Cohort 4: LP-001 Dose 4 (Single)
EXPERIMENTALSingle dose administration of LP-001 with dose 4
Cohort 5: LP-001 Dose 5 (Single)
EXPERIMENTALSingle dose administration of LP-001 with dose 5
Cohort 6: LP-001 Dose 6 (Single)
EXPERIMENTALSingle dose administration of LP-001 with dose 6
Cohort 7: Placebo (Single)
PLACEBO COMPARATORSingle dose administration of placebo drug
Cohort 8: LP-001 Dose 7 (Multiple)
EXPERIMENTALLP-001 with dose 7 was administered 4 times in total
Cohort 9: LP-001 Dose 8 (Multiple)
EXPERIMENTALLP-001 with dose 8 was administered 4 times in total
Cohort 10: Placebo (Multiple)
PLACEBO COMPARATORPlacebo drug was administered 4 times in total
Interventions
A single dose of LP-001 (Dose 1) was administered subcutaneously.
A single dose of LP-001 (Dose 2) was administered subcutaneously.
A single dose of LP-001 (Dose 3) was administered subcutaneously.
A single dose of LP-001 (Dose 4) was administered subcutaneously.
A single dose of LP-001 (Dose 5) was administered subcutaneously.
A single dose of LP-001 (Dose 6) was administered subcutaneously.
A single dose of placebo was administered subcutaneously.
LP-001 (Dose 7) was administered multiple times subcutaneously.
LP-001 (Dose 8) was administered multiple times subcutaneously.
Placebo was administered multiple times subcutaneously.
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).
- Male subjects and their partners, or female subjects, must agree to use one or more non-pharmacological contraceptive measures during the trial and up to 6 months after the end of the trial (such as complete abstinence, condoms, intrauterine devices, partner sterilization, etc.), and should have no plans for sperm or egg donation.
- The upper limits for hemoglobin (Hb) and hematocrit (HCT) are 165 g/L and 49%, respectively, for males, and 150 g/L and 45%, respectively, for females.
- Subjects have a full understanding of the trial's purpose, nature, methods, and potential adverse reactions, voluntarily agree to participate in the trial, and sign the informed consent form.
- Subjects can communicate effectively with the researchers and can comply with the study protocol as specified.
You may not qualify if:
- Family history of early-onset coronary artery disease, including first- or second-degree relatives diagnosed with coronary heart disease or angina before the age of 50; any family history of hematological disorders, such as thrombosis or increased clotting risk, or any family history of deep vein thrombosis, pulmonary embolism, stroke, hemolytic anemia, or hemoglobinopathies; family history of hypertension. Alternatively, the subject has a personal medical history of the aforementioned conditions.
- Presence of liver or kidney diseases or conditions affecting drug absorption, distribution, metabolism, or excretion, including other medical situations such as surgical procedures, trauma, etc. that may interfere with these processes.
- Diagnosed with malignant tumors or having a history of malignant tumors, excluding non-melanoma skin cancer cured for more than 3 years.
- HIV testing positive (HIV-Ab), hepatitis B virus (HBV) testing positive (HBsAg or HBcAb), hepatitis C virus (HCV) positive (HCV-RNA), and specific antibodies for syphilis positive, excluding positive results caused by immunization.
- Abnormal vital signs (reference normal range: sitting systolic blood pressure 90-139 mmHg, diastolic blood pressure 60-89 mmHg, pulse rate 60-100 beats/min; body temperature 35.4-37.7°C) or abnormal electrocardiogram (QTcB≥450 ms), or clinically significant abnormalities in physical examination, laboratory tests, and abdominal ultrasound (as judged by the clinical research doctor).
- Clear history of drug allergy or specific hypersensitivity reactions (asthma, urticaria, allergic rhinitis, eczematous dermatitis); known allergies to the investigational drug and excipients, or allergies to similar drugs; individuals intolerant to subcutaneous injections or with a history of fainting during needle procedures.
- Use of erythropoiesis-stimulating agents or treatment with other biologics within the six months prior to screening.
- Participation in any other drug clinical trial within the 3 months prior to screening or within 5 half-lives of any investigational drug from other clinical trials (selecting the longer time period).
- Pregnant or lactating women or women with the possibility of becoming pregnant.
- Any condition deemed unsuitable for participation in the study by the investigator.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Longbio Pharmalead
Study Sites (1)
Shanghai Public Health Clinical Center
Shanghai, 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 20, 2024
First Posted
March 5, 2024
Study Start
September 3, 2022
Primary Completion
August 16, 2023
Study Completion
August 16, 2023
Last Updated
December 15, 2025
Record last verified: 2025-12