Clinical trial NCT06294275: A Study of Single and Multiple Dose Administration of LP-001 in Healthy Subjects
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Myelodysplastic Syndrome (MDS)
Lead sponsor: Longbio Pharma
Sponsor class: INDUSTRY
First posted: 2024-03-05
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).


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.

Primary outcomes:
measure: Adverse events
timeFrame: Observation for 36 days after administration
Secondary outcomes:
measure: Time to peak concentration (Tmax) of LP-001
timeFrame: Observation for 36 days after administration
measure: Maximum concentration (Cmax) of LP-001
timeFrame: Observation for 36 days after administration
measure: Elimination half-life (t1/2) of LP-001
timeFrame: Observation for 36 days after administration
measure: Area under the concentration-time curve (AUC0-t) of LP-001
timeFrame: Observation for 36 days after administration
measure: Apparent clearance rate (CL/F) of LP-001
timeFrame: Observation for 36 days after administration
measure: Assessment of immunogenicity
timeFrame: Observation for 36 days after administration
measure: Assessment of hemoglobin (Hb) change
timeFrame: Observation for 36 days after administration
measure: Assessment of red blood cell (RBC) count change
timeFrame: Observation for 36 days after administration
measure: Assessment of reticulocyte (Rtc) count change
timeFrame: Observation for 36 days after administration
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Public Health Clinical Center
Study officials:
References: