NCT06294275已完成1 期
A Phase I Clinical Study Evaluating the Safety, Tolerability, and Pharmacokinetics of LP-001 Injection in Healthy Subjects Following Single and Multiple Doses
Longbio Pharma1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2022年9月3日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Adverse events
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
- •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.
研究组 & 干预措施
Cohort 1: LP-001 Dose 1 (Single)
Experimental
Single dose administration of LP-001 with dose 1
干预措施: LP-001 Dose 1 (Single) (Biological)
Cohort 2: LP-001 Dose 2 (Single)
Experimental
Single dose administration of LP-001 with dose 2
干预措施: LP-001 Dose 2 (Single) (Biological)
Cohort 3: LP-001 Dose 3 (Single)
Experimental
Single dose administration of LP-001 with dose 3
干预措施: LP-001 Dose 3 (Single) (Biological)
Cohort 4: LP-001 Dose 4 (Single)
Experimental
Single dose administration of LP-001 with dose 4
干预措施: LP-001 Dose 4 (Single) (Biological)
Cohort 5: LP-001 Dose 5 (Single)
Experimental
Single dose administration of LP-001 with dose 5
干预措施: LP-001 Dose 5 (Single) (Biological)
Cohort 6: LP-001 Dose 6 (Single)
Experimental
Single dose administration of LP-001 with dose 6
干预措施: LP-001 Dose 6 (Single) (Biological)
Cohort 7: Placebo (Single)
Placebo Comparator
Single dose administration of placebo drug
干预措施: Placebo (Single) (Biological)
Cohort 8: LP-001 Dose 7 (Multiple)
Experimental
LP-001 with dose 7 was administered 4 times in total
干预措施: LP-001 Dose 7 (Multiple) (Biological)
Cohort 9: LP-001 Dose 8 (Multiple)
Experimental
LP-001 with dose 8 was administered 4 times in total
干预措施: LP-001 Dose 8 (Multiple) (Biological)
Cohort 10: Placebo (Multiple)
Placebo Comparator
Placebo drug was administered 4 times in total
干预措施: Placebo (Multiple) (Biological)
结局指标
主要结局
Adverse events
时间窗: Observation for 36 days after administration
Number of subjects with treatment-related Treatment Emergent Adverse Events (TEAEs).
次要结局
- Apparent clearance rate (CL/F) of LP-001(Observation for 36 days after administration)
- Assessment of red blood cell (RBC) count change(Observation for 36 days after administration)
- Assessment of reticulocyte (Rtc) count change(Observation for 36 days after administration)
- Time to peak concentration (Tmax) of LP-001(Observation for 36 days after administration)
- Maximum concentration (Cmax) of LP-001(Observation for 36 days after administration)
- Elimination half-life (t1/2) of LP-001(Observation for 36 days after administration)
- Area under the concentration-time curve (AUC0-t) of LP-001(Observation for 36 days after administration)
- Assessment of immunogenicity(Observation for 36 days after administration)
- Assessment of hemoglobin (Hb) change(Observation for 36 days after administration)
研究者
研究点 (1)
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