Safety, Tolerability and Pharmacokinetics of a Single Subcutaneous Administration of SP16-a SERPIN-like, Small Peptide Agonist of the Low Density Lipoprotein-like Receptor 1-in Healthy Individuals
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Preliminary Safety Assessment: Occurence of adverse events
研究概览
简要总结
This study is a randomized, double-blind, placebo-controlled Phase 1 Clinical Trial of 24 healthy individuals to test the safety, tolerability and pharmacokinetics of a single subcutaneous administration of Serpin Peptide 16 (SP16), a Serine Protease Inhibitor (Serpin)-like, small peptide agonist of the Low Density Lipoprotein Receptor-like Protein 1 (LRPP1) hypothesized to have anti-inflammatory activity.
详细描述
One of the major determinants for outcome in patients with acute myocardial infarction (AMI) is the degree of inflammatory response. SP16 is a synthetic anti-inflammatory peptide developed to reproduce the anti-inflammatory activities of naturally occurring Serpins and has been tested as a treatment for AMI in mice. This Phase I trial will be the first to test the hypothesis that a single subcutaneous administration of SP16 is safe and well tolerated in healthy individuals, while also assessing the pharmacokinetic parameters of three different dosages. Participants will undergo direct clinical monitoring for up to 12 hours after drug administration. Additionally, participants will follow up with the same assessments at 24 hours, 48-72 hours and 7 days post drug administration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Written informed consent
- •Age 18 to 59 years
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Ability to take oral medication and be willing to adhere to the medication regimen
- •For females of reproductive potential: Use of highly effective contraception
- •For males of reproductive potential: Use of condoms
排除标准
- •Acute or chronic illness affecting organ function or requiring medications (including, but not limited to, cardiovascular, hepatic, renal hematologic, neurologic, dermatologic, psychiatric, or rheumatologic disease);
- •Febrile illness within the previous 14 days;
- •Known allergic reactions to components of the study agent;
- •Treatment with another investigational drug or other intervention within 30 days;
- •Current tobacco use or tobacco use within 60 days;
- •Household contacts who are immunocompromised;
- •Chronic infection(s) (of any kind);
- •Malignancy (of any kind);
- •Substance abuse disorder(s);
- •Pregnancy or breastfeeding;
- •Any other conditions that would place the subject at increased risk of adverse events or interfere with the conduct or interpretation of the study, in the opinion of the investigators.
研究组 & 干预措施
SP16 0.0125
0.0125 mg/kg of SP16 will be administered by subcutaneous injection once
干预措施: SP16 (Drug)
SP16 0.050
0.050 mg/kg of SP16 will be administered by subcutaneous injection once
干预措施: SP16 (Drug)
SP16 0.20
0.20 mg/kg of SP16 will be administered by subcutaneous injection once
干预措施: SP16 (Drug)
placebo
Placebo (sterile saline) will be administered by subcutaneous injection once
干预措施: Placebos (Drug)
结局指标
主要结局
Preliminary Safety Assessment: Occurence of adverse events
时间窗: 7 days follow-up
Occurence of adverse events
次要结局
- Volume of distribution of SP16 in healthy subjects(7 days)
- Clearance of SP16 in healthy subjects(7 days)