Phase 1 Clinical Study of the Safety and Pharmacokinetics of Rescue Liposome in Healthy Adult Participants
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Safety: Number of Treatment Related Adverse Events
研究概览
简要总结
This is a Phase 1 study to assess the safety and tolerability of the liposomal product in healthy participants.
详细描述
This is a Phase 1 clinical trial consisting of a dose-escalation and dose-expansion study to evaluate the safety, clinical tolerability, and pharmacokinetics of the intravenous liposomal dispersion product in healthy participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Sign the informed consent form (ICF).
- •Age ≥ 18 years and ≤ 30 years.
- •Body mass index (BMI) between 18.5 and 30.0 kg/m².
- •Be able to complete the study in accordance with the protocol requirements.
- •Health status: no mental disorders and no history of diseases of the cardiovascular, nervous, respiratory, digestive, urinary, or endocrine systems, and no metabolic abnormalities.
- •Willingness to use effective contraception.
排除标准
- •Having donated blood within 6 months prior to admission or having experienced significant blood loss (> 450 mL).
- •Having participated in any clinical trial involving investigational drugs within 6 months prior to admission in the study.
- •Positive test for hepatitis B, hepatitis C, syphilis, and/or HIV.
- •Safety laboratory values outside the normal reference range.
研究组 & 干预措施
CRIS115 treatment
Injectable liposomal dispersion with a concentration of 22.08 mg/mL
干预措施: liposome dispersion (Drug)
结局指标
主要结局
Safety: Number of Treatment Related Adverse Events
时间窗: From enrollment to the end of treatment at 2 weeks.
The severity/intensity (grade 1 to grade 5) of adverse events will be assessed by the investigator as "unlikely," "possibly," or "probably" related to the investigational drug. An adverse event will be considered causally related to the use of the investigational drug when the causality assessment was "probable" or "possible."
Safety: Number of Clinically Significant (CS) Changes in Physical Examination.
时间窗: From enrollment to the end of treatment at 2 weeks.
A complete physical examination includes assessments of selected body systems, at the investigator's discretion, but covers at least the cardiovascular, pulmonary, and neurological systems. Examination results will be documented in the eCRF as normal, abnormal without clinical significance (CNS), or abnormal with clinical significance (CS). Post-dose physical examination findings classified as abnormal CS will be reported as adverse events (AEs).
次要结局
- Cmax(From time 0 (time of dosing) to 10,080 minutes after dose (concentration measured at timepoints pre-dose and 0; 5; 10; 15; 20; 40; 50; 60; 70; 90 120; 240; 360; 540; 720; 1,440; 2,160; 2,880 and 10,080 minutes post-dose).)
- AUC(From time 0 (time of dosing) to 10,080 minutes after dose (concentration measured at timepoints pre-dose and 0; 5; 10; 15; 20; 40; 50; 60; 70; 90 120; 240; 360; 540; 720; 1,440; 2,160; 2,880 and 10,080 minutes post-dose).)
- T1/2(z)(From time 0 (time of dosing) to 10,080 minutes after dose (concentration measured at timepoints pre-dose and 0; 5; 10; 15; 20; 40; 50; 60; 70; 90 120; 240; 360; 540; 720; 1,440; 2,160; 2,880 and 10,080 minutes post-dose).)