NCT06294301已完成1 期
To Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Escalating Single and Multiple Doses of LP-005 in Healthy Volunteers
Longbio Pharma1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2023年11月23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-005 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-005 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).
- •Vaccination: Meningococcal Conjugate Vaccine, Serogroups A, C, W, Y (MPV-ACYW) meningococcal conjugate vaccine and Streptococcus pneumoniae vaccine should be given 14 days or more before randomisation.
- •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
- •Participants who are immunocompromised or have one of the following underlying diseases: anatomic absence of spleen (including sickle cell disease); congenital complement component deficiencies (complement component 3 and complement component 4).
- •Any history of Neisseria gonorrhea, meningitis infection, and Guillain-Barré syndrome.
- •Contraindications to meningococcal vaccination (previous medical history such as epilepsy or other brain disorders).
- •Presence or suspicion of active viral, bacterial, fungal, or parasitic infection, including herpes, shingles, or cold sores, within 14 days prior to screening.
- •History of unexplained recurrent infections, or use of systemic antibiotics within 90 days prior to dosing.
- •Malignancy or history of malignancy, except non-melanoma skin cancer cured for more than 3 years.
- •Positive HIV test (HIV-Ab), positive hepatitis B virus (HBV) test (HBsAg), positive hepatitis C virus (HCV), positive anti-syphilis helix-specific antibodies.
- •Participation in a clinical trial of any other drug within 3 months prior to screening or within 5 half-lives of other clinical trial drugs (selecting the longer time period).
- •Women who are pregnant, breastfeeding, or at risk of pregnancy.
- •Any condition deemed unsuitable for study participation by the investigator.
研究组 & 干预措施
Cohort 1: LP-005 Dose 1 (Single)
Experimental
干预措施: LP-005 Dose 1 (Single) (Biological)
Cohort 2: LP-005 Dose 2 (Single)
Experimental
干预措施: LP-005 Dose 2 (Single) (Biological)
Cohort 3: LP-005 Dose 3 (Single)
Experimental
干预措施: LP-005 Dose 3 (Single) (Biological)
Cohort 4: LP-005 Dose 4 (Single)
Experimental
干预措施: LP-005 Dose 4 (Single) (Biological)
Cohort 5: LP-005 Dose 5 (Single)
Experimental
干预措施: LP-005 Dose 5 (Single) (Biological)
Cohort 6: LP-005 Dose 6 (Single)
Experimental
干预措施: LP-005 Dose 6 (Single) (Biological)
Cohort 7: Placebo (Single)
Placebo Comparator
干预措施: Placebo (Single) (Biological)
Cohort 8: LP-005 Dose 7 (Multiple)
Experimental
干预措施: LP-005 Dose 7 (Multiple) (Biological)
Cohort 9: LP-005 Dose 8 (Multiple)
Experimental
干预措施: LP-005 Dose 8 (Multiple) (Biological)
Cohort 10: LP-005 Dose 9 (Multiple)
Experimental
干预措施: LP-005 Dose 9 (Multiple) (Biological)
Cohort 11: 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 78 days after administration
Number of subjects with treatment-related Treatment Emergent Adverse Events (TEAEs).
次要结局
- Assessment of complement C5 activity(Observation for 78 days after administration)
- Maximum concentration (Cmax) of LP-005(Observation for 78 days after administration)
- Elimination half-life (t1/2) of LP-005(Observation for 78 days after administration)
- Assessment of complement C3b activity(Observation for 78 days after administration)
- Apparent clearance rate (CL/F) of LP-005(Observation for 78 days after administration)
- Area under the concentration-time curve (AUC0-t) of LP-005(Observation for 78 days after administration)
- Time to peak concentration (Tmax) of LP-005(Observation for 78 days after administration)
- Assessment of immunogenicity(Observation for 78 days after administration)
研究者
研究点 (1)
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