A Study of Single and Multiple Dose Administration of LP-001 in Healthy Subjects
NCT ID: NCT06294275
Last Updated: 2025-12-15
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
68 participants
INTERVENTIONAL
2022-09-03
2023-08-16
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-001 Dose 1 (Single)
Single dose administration of LP-001 with dose 1
LP-001 Dose 1 (Single)
A single dose of LP-001 (Dose 1) was administered subcutaneously.
Cohort 2: LP-001 Dose 2 (Single)
Single dose administration of LP-001 with dose 2
LP-001 Dose 2 (Single)
A single dose of LP-001 (Dose 2) was administered subcutaneously.
Cohort 3: LP-001 Dose 3 (Single)
Single dose administration of LP-001 with dose 3
LP-001 Dose 3 (Single)
A single dose of LP-001 (Dose 3) was administered subcutaneously.
Cohort 4: LP-001 Dose 4 (Single)
Single dose administration of LP-001 with dose 4
LP-001 Dose 4 (Single)
A single dose of LP-001 (Dose 4) was administered subcutaneously.
Cohort 5: LP-001 Dose 5 (Single)
Single dose administration of LP-001 with dose 5
LP-001 Dose 5 (Single)
A single dose of LP-001 (Dose 5) was administered subcutaneously.
Cohort 6: LP-001 Dose 6 (Single)
Single dose administration of LP-001 with dose 6
LP-001 Dose 6 (Single)
A single dose of LP-001 (Dose 6) was administered subcutaneously.
Cohort 7: Placebo (Single)
Single dose administration of placebo drug
Placebo (Single)
A single dose of placebo was administered subcutaneously.
Cohort 8: LP-001 Dose 7 (Multiple)
LP-001 with dose 7 was administered 4 times in total
LP-001 Dose 7 (Multiple)
LP-001 (Dose 7) was administered multiple times subcutaneously.
Cohort 9: LP-001 Dose 8 (Multiple)
LP-001 with dose 8 was administered 4 times in total
LP-001 Dose 8 (Multiple)
LP-001 (Dose 8) was administered multiple times subcutaneously.
Cohort 10: Placebo (Multiple)
Placebo drug was administered 4 times in total
Placebo (Multiple)
Placebo was administered multiple times subcutaneously.
Interventions
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LP-001 Dose 1 (Single)
A single dose of LP-001 (Dose 1) was administered subcutaneously.
LP-001 Dose 2 (Single)
A single dose of LP-001 (Dose 2) was administered subcutaneously.
LP-001 Dose 3 (Single)
A single dose of LP-001 (Dose 3) was administered subcutaneously.
LP-001 Dose 4 (Single)
A single dose of LP-001 (Dose 4) was administered subcutaneously.
LP-001 Dose 5 (Single)
A single dose of LP-001 (Dose 5) was administered subcutaneously.
LP-001 Dose 6 (Single)
A single dose of LP-001 (Dose 6) was administered subcutaneously.
Placebo (Single)
A single dose of placebo was administered subcutaneously.
LP-001 Dose 7 (Multiple)
LP-001 (Dose 7) was administered multiple times subcutaneously.
LP-001 Dose 8 (Multiple)
LP-001 (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 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).
3. 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.
4. 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.
5. 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.
6. Subjects can communicate effectively with the researchers and can comply with the study protocol as specified.
Exclusion Criteria
2. 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.
3. Diagnosed with malignant tumors or having a history of malignant tumors, excluding non-melanoma skin cancer cured for more than 3 years.
4. 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.
5. 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).
6. 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.
7. Use of erythropoiesis-stimulating agents or treatment with other biologics within the six months prior to screening.
8. 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).
9. Pregnant or lactating women or women with the possibility of becoming pregnant.
10. Any condition deemed unsuitable for participation in the study by the investigator.
18 Years
50 Years
ALL
Yes
Sponsors
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Longbio Pharma
INDUSTRY
Responsible Party
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Locations
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Shanghai Public Health Clinical Center
Shanghai, , China
Countries
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Other Identifiers
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P-10-LP001-2022-01
Identifier Type: -
Identifier Source: org_study_id
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