NCT06483373招募中早期 1 期
A Single and Multiple Dose-escalation, and Food Effects of Phase I Clinical Study to Evaluate the Tolerability/Safety/Pharmacokinetics of SPH7854 Granules in Healthy Subjects.
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 入组人数
- 111
- 试验地点
- 1
- 主要终点
- Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
研究概览
简要总结
To evaluate the safety of SPH7854 in healthy subjects.
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
- 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
- •Volunteer to participate in clinical research; Fully understand and know the study and sign the informed consent；
- •Healthy volunteers;
- •Before receiving the investigational drug, the examination results were normal or clinically insignificant;
- •Subjects who have no fertility plan/sperm donation/egg donation plan and voluntarily take effective contraceptive measures, from signing the informed consent to the prescribed time after the last dosing.
排除标准
- •Female subjects who are breastfeeding or have positive pregnancy results;
- •Subjects with chronic, unstable, or recurrent disease or surgery history who are judged by the investigator to be ineligible before signing informed consent;
- •Subjects suffering from allergic diseases or having a history of severe allergies;
- •Subjects who took the drug or food prohibited by the protocol prior to the first dose;
- •Subjects with evidence of infection who could not be enrolled according to the investigator's judgement;
- •Other circumstances that meet the protocol exclusion criteria.
研究组 & 干预措施
SPH7854
Experimental
干预措施: SPH7854 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
时间窗: Approximately 2 years
Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
次要结局
- PK(Pharmacokinetics):Tmax(Approximately 2 years)
- PK(Pharmacokinetics):AUC(Approximately 2 years)
- PK(Pharmacokinetics):Cmax(Approximately 2 years)
研究者
研究点 (1)
Loading locations...
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