First human study of LP-001 checks safety before MDS fight
NCT ID NCT06294275
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study tested the safety and tolerability of a new drug called LP-001 in 68 healthy adults aged 18 to 50. The goal was to see how the body handles single and multiple doses, not to treat any disease. Results will help guide future research for myelodysplastic syndrome (MDS), a blood disorder.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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68 people
The number who actually took part.
- Started
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Sep 2022
- Finished
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Aug 2023
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 50 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Shanghai Public Health Clinical Center
Shanghai, China
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Other studies related to the condition(s) this trial covers.
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