NCT06294288已完成1 期
To Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Escalating Single and Multiple Doses of LP-003 in Healthy Volunteers
Longbio Pharma1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年7月13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
- 60
- 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-003 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-003 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 must weigh ≥50 kg, and female subjects must weigh ≥45 kg, with a BMI between 19.0 and 28.0 kg/m² (inclusive).
- •Male subjects and their partners or female subjects must agree to use one or more non-pharmaceutical contraceptive methods (such as total abstinence, condoms, Iuds, partner ligation, etc.) during the trial period and for 6 months after the trial, and do not plan to donate sperm or eggs.
- •The subjects fully understand the purpose, nature, method and possible adverse reactions of the experiment, and voluntarily participate in the experiment and sign the informed consent.
- •The subjects were able to communicate well with the researchers and complete the study according to the protocol.
排除标准
- •People who are allergic to the experimental drug and any of its excipients, have a history of allergy to monoclonal antibodies, and are allergic to multiple drugs and food.
- •Patients who have been or are currently suffering from any clinically serious diseases such as circulatory system, endocrine system, nervous system, digestive system, respiratory system, urogenital system, hematology, immunology, psychiatric and metabolic abnormalities, or any other diseases that can interfere with the test results.
- •Patients who had undergone surgery within 3 months before the trial that the researchers judged would affect drug absorption, distribution, metabolism, and excretion, or had surgery within 4 weeks prior to the trial, or planned to have surgery during the study period.
- •Any history of infection within 14 days prior to administration.
- •A person who is currently infected with parasites or has traveled to an endemic area within the last 3 months or 24 weeks prior to administration.
- •Pregnant and lactating women.
- •Hepatitis B surface antigen, hepatitis C virus antibodies, human immunodeficiency virus antibodies, treponema pallidum antibodies A positive person.
- •Patients who have received any biological agent (including antibodies or derivatives such as omalizumab) within 16 weeks prior to administration (or 5 half-lives, selecting the longer time period).
- •Participants who had participated in other clinical trials within 3 months prior to screening.
- •The investigator deems any condition unsuitable for study participation.
研究组 & 干预措施
Cohort 1: LP-003 Dose 1 (Single)
Experimental
干预措施: LP-003 Dose 1 (Single) (Biological)
Cohort 2: LP-003 Dose 2 (Single)
Experimental
干预措施: LP-003 Dose 2 (Single) (Biological)
Cohort 3: LP-003 Dose 3 (Single)
Experimental
干预措施: LP-003 Dose 3 (Single) (Biological)
Cohort 4: LP-003 Dose 4 (Single)
Experimental
干预措施: LP-003 Dose 4 (Single) (Biological)
Cohort 5: LP-003 Dose 5 (Single)
Experimental
干预措施: LP-003 Dose 5 (Single) (Biological)
Cohort 6: Placebo (Single)
Placebo Comparator
干预措施: Placebo (Single) (Biological)
Cohort 7: LP-003 Dose 6 (Multiple)
Experimental
干预措施: LP-003 Dose 6 (Multiple) (Biological)
Cohort 8: LP-003 Dose 7 (Multiple)
Experimental
干预措施: LP-003 Dose 7 (Multiple) (Biological)
Cohort 9: LP-003 Dose 8 (Multiple)
Experimental
干预措施: LP-003 Dose 8 (Multiple) (Biological)
Cohort 10: Placebo (Multiple)
Placebo Comparator
干预措施: Placebo (Multiple) (Biological)
结局指标
主要结局
Adverse events
时间窗: Observation for 280 days after administration
Number of subjects with treatment-related Treatment Emergent Adverse Events (TEAEs).
次要结局
- Elimination half-life (t1/2) of LP-003(Observation for 280 days after administration)
- Apparent clearance rate (CL/F) of LP-003(Observation for 280 days after administration)
- Assessment of immunogenicity(Observation for 280 days after administration)
- Assessment of total immunoglobulin E (IgE)(Observation for 168 days after administration)
- Maximum concentration (Cmax) of LP-003(Observation for 280 days after administration)
- Area under the concentration-time curve (AUC0-t) of LP-003(Observation for 280 days after administration)
- Time to peak concentration (Tmax) of LP-003(Observation for 280 days after administration)
- Assessment of free IgE(Observation for 168 days after administration)
研究者
研究点 (1)
Loading locations...
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