NCT06839131招募中1 期
A Randomized, Double-Blind, Placebo-Controlled, Phase I Study to Evaluate Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of SPH9788 Tablet in Chinese Healthy Subjects.
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- (一) Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs).
研究概览
简要总结
The purpose of the study is to evaluate the safety of SPH9788 tablets in healthy subjects.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and female subjects aged from 18 to 45 years;
- •Subject has a Body Mass Index (BMI) between 18.5 and 28.0 kg/m2 at screening and the weight of male subjects is not less than 50 kg, and the weight of female subjects is not less than 45 kg;;
- •Subjects who voluntarily participate and sign informed consent form;
- •Subjects who can communicate well with investigator and comply with the lifestyle restrictions specified in the protocol, and cooperate to complete the trial procedure;
- •Subjects willing to use reliable contraceptive methods throughout the trial and for 6 months after trial completion.
排除标准
- •Medical history (current or past) that in the investigator's judgment may interfere with trial participation;
- •Surgical/medical conditions that may significantly affect drug pharmacokinetics (absorption, distribution, metabolism, excretion) or pose safety risks;
- •Occurrence of protocol-defined exclusionary events within 3 months prior to investigational product administration;
- •Use of any prescription/non-prescription medications (including herbal products) within 2 weeks prior to dosing;
- •Known hypersensitivity to any component of the investigational product or history of severe allergic reactions;
- •Positive serology for hepatitis B surface antigen, hepatitis C antibody, HIV antibody, and syphilis serum reaction;
- •Substance abuse history within 1 year prior to screening or positive urine drug screen;
- •Alcohol abuse history within 1 year or positive alcohol breath test;
- •Smoking ≥5 cigarettes/day on average during 3 months prior to screening;
- •Pregnant or lactating women;
- •Positive pregnancy test before study drug administration, or male and female subjects who refuse to use effective contraceptive methods during and for 6 months post-trial, or who have plans to donate sperm or eggs;
- •Poor compliance or any other condition that in the investigator's opinion renders the subject unsuitable for trial participation.
研究组 & 干预措施
Placebo Comparator
Placebo Comparator
干预措施: Placebo (Drug)
SPH9788
Experimental
干预措施: SPH9788 (Drug)
结局指标
主要结局
(一) Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs).
时间窗: Approximately 1 year
Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs).
次要结局
- PK(Pharmacokinetics):Tmax(Approximately 1 year)
- PK(Pharmacokinetics):Cmax(Approximately 1 year)
- PK(Pharmacokinetics):AUC(Approximately 1 year)
研究者
研究点 (1)
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