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Trial Title: A Study of Single and Multiple Dose Administration of LP-001 in Healthy Subjects

NCT ID: NCT06294275

Condition: Myelodysplastic Syndrome (MDS)

Conditions: Official terms:
Preleukemia
Myelodysplastic Syndromes

Study type: Interventional

Study phase: Phase 1

Overall status: Active, not recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Triple (Participant, Care Provider, Investigator)

Intervention:

Intervention type: Biological
Intervention name: LP-001 Dose 1 (Single)
Description: A single dose of LP-001 (Dose 1) was administered subcutaneously.
Arm group label: Cohort 1: LP-001 Dose 1 (Single)

Intervention type: Biological
Intervention name: LP-001 Dose 2 (Single)
Description: A single dose of LP-001 (Dose 2) was administered subcutaneously.
Arm group label: Cohort 2: LP-001 Dose 2 (Single)

Intervention type: Biological
Intervention name: LP-001 Dose 3 (Single)
Description: A single dose of LP-001 (Dose 3) was administered subcutaneously.
Arm group label: Cohort 3: LP-001 Dose 3 (Single)

Intervention type: Biological
Intervention name: LP-001 Dose 4 (Single)
Description: A single dose of LP-001 (Dose 4) was administered subcutaneously.
Arm group label: Cohort 4: LP-001 Dose 4 (Single)

Intervention type: Biological
Intervention name: LP-001 Dose 5 (Single)
Description: A single dose of LP-001 (Dose 5) was administered subcutaneously.
Arm group label: Cohort 5: LP-001 Dose 5 (Single)

Intervention type: Biological
Intervention name: LP-001 Dose 6 (Single)
Description: A single dose of LP-001 (Dose 6) was administered subcutaneously.
Arm group label: Cohort 6: LP-001 Dose 6 (Single)

Intervention type: Biological
Intervention name: Placebo (Single)
Description: A single dose of placebo was administered subcutaneously.
Arm group label: Cohort 7: Placebo (Single)

Intervention type: Biological
Intervention name: LP-001 Dose 7 (Multiple)
Description: LP-001 (Dose 7) was administered multiple times subcutaneously.
Arm group label: Cohort 8: LP-001 Dose 7 (Multiple)

Intervention type: Biological
Intervention name: LP-001 Dose 8 (Multiple)
Description: LP-001 (Dose 8) was administered multiple times subcutaneously.
Arm group label: Cohort 9: LP-001 Dose 8 (Multiple)

Intervention type: Biological
Intervention name: Placebo (Multiple)
Description: Placebo was administered multiple times subcutaneously.
Arm group label: Cohort 10: Placebo (Multiple)

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).

Criteria for eligibility:
Criteria:
Inclusion Criteria: 1. Healthy males or females aged 18 through 50 years. 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: 1. 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. 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.

Gender: All

Minimum age: 18 Years

Maximum age: 50 Years

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: Shanghai Public Health Clinical Center

Address:
City: Shanghai
Country: China

Start date: September 16, 2022

Completion date: April 6, 2024

Lead sponsor:
Agency: Longbio Pharma
Agency class: Industry

Source: Longbio Pharma

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06294275

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