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