Myelodysplastic Syndrome (MDS)Phase 1NCT06294275
A Study of Single and Multiple Dose Administration of LP-001 in Healthy Subjects
A Phase 1 study testing LP-001 Dose 1 (Single), LP-001 Dose 2 (Single) and LP-001 Dose 3 (Single) in people with Myelodysplastic Syndrome (MDS), run by Longbio Pharma at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Myelodysplastic Syndrome (MDS)
- What is being tested?
- LP-001 Dose 1 (Single), LP-001 Dose 2 (Single) and LP-001 Dose 3 (Single)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteChina
- Study dates
- 3 Sep 2022to 16 Aug 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Clinical Study Evaluating the Safety, Tolerability, and Pharmacokinetics of LP-001 Injection in Healthy Subjects Following Single and Multiple Doses
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).
- Conditions
- Myelodysplastic Syndrome (MDS)
- Being tested
- LP-001 Dose 1 (Single), LP-001 Dose 2 (Single), LP-001 Dose 3 (Single), LP-001 Dose 4 (Single), LP-001 Dose 5 (Single)
- Medical subject headings
- Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LP-001 Dose 1 (Single)Biological
A single dose of LP-001 (Dose 1) was administered subcutaneously.
LP-001 Dose 2 (Single)Biological
A single dose of LP-001 (Dose 2) was administered subcutaneously.
LP-001 Dose 3 (Single)Biological
A single dose of LP-001 (Dose 3) was administered subcutaneously.
LP-001 Dose 4 (Single)Biological
A single dose of LP-001 (Dose 4) was administered subcutaneously.
LP-001 Dose 5 (Single)Biological
A single dose of LP-001 (Dose 5) was administered subcutaneously.
LP-001 Dose 6 (Single)Biological
A single dose of LP-001 (Dose 6) was administered subcutaneously.
Placebo (Single)Biological
A single dose of placebo was administered subcutaneously.
LP-001 Dose 7 (Multiple)Biological
LP-001 (Dose 7) was administered multiple times subcutaneously.
LP-001 Dose 8 (Multiple)Biological
LP-001 (Dose 8) was administered multiple times subcutaneously.
Placebo (Multiple)Biological
Placebo was administered multiple times subcutaneously.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: LP-001 Dose 1 (Single) | Experimental | Single dose administration of LP-001 with dose 1 Receives: Biological: LP-001 Dose 1 (Single) |
| Cohort 2: LP-001 Dose 2 (Single) | Experimental | Single dose administration of LP-001 with dose 2 Receives: Biological: LP-001 Dose 2 (Single) |
| Cohort 3: LP-001 Dose 3 (Single) | Experimental | Single dose administration of LP-001 with dose 3 Receives: Biological: LP-001 Dose 3 (Single) |
| Cohort 4: LP-001 Dose 4 (Single) | Experimental | Single dose administration of LP-001 with dose 4 Receives: Biological: LP-001 Dose 4 (Single) |
| Cohort 5: LP-001 Dose 5 (Single) | Experimental | Single dose administration of LP-001 with dose 5 Receives: Biological: LP-001 Dose 5 (Single) |
| Cohort 6: LP-001 Dose 6 (Single) | Experimental | Single dose administration of LP-001 with dose 6 Receives: Biological: LP-001 Dose 6 (Single) |
| Cohort 7: Placebo (Single) | Placebo comparator | Single dose administration of placebo drug Receives: Biological: Placebo (Single) |
| Cohort 8: LP-001 Dose 7 (Multiple) | Experimental | LP-001 with dose 7 was administered 4 times in total Receives: Biological: LP-001 Dose 7 (Multiple) |
| Cohort 9: LP-001 Dose 8 (Multiple) | Experimental | LP-001 with dose 8 was administered 4 times in total Receives: Biological: LP-001 Dose 8 (Multiple) |
| Cohort 10: Placebo (Multiple) | Placebo comparator | Placebo drug was administered 4 times in total Receives: Biological: Placebo (Multiple) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Number of subjects with treatment-related Treatment Emergent Adverse Events (TEAEs).
Measured: Observation for 36 days after administration
Secondary outcomes (9)
Time to peak concentration (Tmax) of LP-001
The time when the blood drug concentration reaches its peak after a single dose of medication.
Measured: Observation for 36 days after administration
Maximum concentration (Cmax) of LP-001
The maximum concentration of LP-001 in the bloodstream after administration.
Measured: Observation for 36 days after administration
Elimination half-life (t1/2) of LP-001
The time required for the concentration of LP-005 in the bloodstream to decrease by half.
Measured: Observation for 36 days after administration
Area under the concentration-time curve (AUC0-t) of LP-001
The time required for the concentration of LP-005 in the bloodstream to decrease by half.
Measured: Observation for 36 days after administration
Apparent clearance rate (CL/F) of LP-001
The ratio of drug clearance to drug concentration, represents the apparent clearance of a drug after administration, adjusted for bioavailability.
Measured: Observation for 36 days after administration
Assessment of immunogenicity
The proportion of anti drug antibody (ADA) positive subjects at different detection time points.
Measured: Observation for 36 days after administration
Assessment of hemoglobin (Hb) change
Concentration of Hemoglobin changes from baseline at various time points of assessment.
Measured: Observation for 36 days after administration
Assessment of red blood cell (RBC) count change
The count of RBC changes from baseline at various time points of assessment.
Measured: Observation for 36 days after administration
Assessment of reticulocyte (Rtc) count change
The count of Rtc changes from baseline at various time points of assessment.
Measured: Observation for 36 days after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2024
- Study start3 Sep 2022
- Primary completion16 Aug 2023
- Study completion16 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myelodysplastic Syndrome (MDS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Longbio Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06294275
- Sponsor's protocol ID
- P-10-LP001-2022-01
- Status last verified
- Dec 2025
- First submitted
- 20 Feb 2024
- Last updated
- 15 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Study Evaluating the Safety, Tolerability, and Pharmacokinetics of LP-001 Injection in Healthy Subjects Following Single and Multiple Doses
- ClinicalTrials.gov ID
- NCT06294275
- Acronym / sponsor ID
- P-10-LP001-2022-01
- Conditions
- Myelodysplastic Syndrome (MDS)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Longbio PharmaIndustry (pharma, biotech, devices)
- Study start
- 3 Sep 2022 (actual)
- Primary completion
- 16 Aug 2023 (actual)
- Study completion
- 16 Aug 2023 (actual)
- First posted
- 5 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: LP-001 Dose 1 (Single) | Experimental | Biological: LP-001 Dose 1 (Single)Single dose administration of LP-001 with dose 1 |
| Cohort 2: LP-001 Dose 2 (Single) | Experimental | Biological: LP-001 Dose 2 (Single)Single dose administration of LP-001 with dose 2 |
| Cohort 3: LP-001 Dose 3 (Single) | Experimental | Biological: LP-001 Dose 3 (Single)Single dose administration of LP-001 with dose 3 |
| Cohort 4: LP-001 Dose 4 (Single) | Experimental | Biological: LP-001 Dose 4 (Single)Single dose administration of LP-001 with dose 4 |
| Cohort 5: LP-001 Dose 5 (Single) | Experimental | Biological: LP-001 Dose 5 (Single)Single dose administration of LP-001 with dose 5 |
| Cohort 6: LP-001 Dose 6 (Single) | Experimental | Biological: LP-001 Dose 6 (Single)Single dose administration of LP-001 with dose 6 |
| Cohort 7: Placebo (Single) | Placebo comparator | Biological: Placebo (Single)Single dose administration of placebo drug |
| Cohort 8: LP-001 Dose 7 (Multiple) | Experimental | Biological: LP-001 Dose 7 (Multiple)LP-001 with dose 7 was administered 4 times in total |
| Cohort 9: LP-001 Dose 8 (Multiple) | Experimental | Biological: LP-001 Dose 8 (Multiple)LP-001 with dose 8 was administered 4 times in total |
| Cohort 10: Placebo (Multiple) | Placebo comparator | Biological: Placebo (Multiple)Placebo drug was administered 4 times in total |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (10 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LP-001 Dose 1 (Single)A single dose of LP-001 (Dose 1) was administered subcutaneously. | Biological | Cohort 1: LP-001 Dose 1 (Single) |
| LP-001 Dose 2 (Single)A single dose of LP-001 (Dose 2) was administered subcutaneously. | Biological | Cohort 2: LP-001 Dose 2 (Single) |
| LP-001 Dose 3 (Single)A single dose of LP-001 (Dose 3) was administered subcutaneously. | Biological | Cohort 3: LP-001 Dose 3 (Single) |
| LP-001 Dose 4 (Single)A single dose of LP-001 (Dose 4) was administered subcutaneously. | Biological | Cohort 4: LP-001 Dose 4 (Single) |
| LP-001 Dose 5 (Single)A single dose of LP-001 (Dose 5) was administered subcutaneously. | Biological | Cohort 5: LP-001 Dose 5 (Single) |
| LP-001 Dose 6 (Single)A single dose of LP-001 (Dose 6) was administered subcutaneously. | Biological | Cohort 6: LP-001 Dose 6 (Single) |
| Placebo (Single)A single dose of placebo was administered subcutaneously. | Biological | Cohort 7: Placebo (Single) |
| LP-001 Dose 7 (Multiple)LP-001 (Dose 7) was administered multiple times subcutaneously. | Biological | Cohort 8: LP-001 Dose 7 (Multiple) |
| LP-001 Dose 8 (Multiple)LP-001 (Dose 8) was administered multiple times subcutaneously. | Biological | Cohort 9: LP-001 Dose 8 (Multiple) |
| Placebo (Multiple)Placebo was administered multiple times subcutaneously. | Biological | Cohort 10: Placebo (Multiple) |
Primary outcome
Adverse events
Time frame: Observation for 36 days after administration
Number of subjects with treatment-related Treatment Emergent Adverse Events (TEAEs).
9 secondary outcomes
Time to peak concentration (Tmax) of LP-001
Time frame: Observation for 36 days after administration
Maximum concentration (Cmax) of LP-001
Time frame: Observation for 36 days after administration
Elimination half-life (t1/2) of LP-001
Time frame: Observation for 36 days after administration
Area under the concentration-time curve (AUC0-t) of LP-001
Time frame: Observation for 36 days after administration
Apparent clearance rate (CL/F) of LP-001
Time frame: Observation for 36 days after administration
Assessment of immunogenicity
Time frame: Observation for 36 days after administration
Assessment of hemoglobin (Hb) change
Time frame: Observation for 36 days after administration
Assessment of red blood cell (RBC) count change
Time frame: Observation for 36 days after administration
Assessment of reticulocyte (Rtc) count change
Time frame: Observation for 36 days after administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LP-001 Dose 1 (Single), LP-001 Dose 2 (Single) and LP-001 Dose 3 (Single) in people with Myelodysplastic Syndrome (MDS), run by Longbio Pharma at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (time frame: Observation for 36 days after administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2025.