A Phase I, Single and Multiple Dose, to Evaluate the Safety, Tolerability, and Pharmacokinetics of SSD8432 and SSD8432 Co-administrated in Healthy Adult Subjects
试验速览
- 阶段
- 1 期
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- The Adverse events of SSD8432(Part A~D)
研究概览
简要总结
This is a Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of SSD8432 in Healthy Adult Subjects
详细描述
108 healthy adult subjects (including 72 subjects in Part A to C, 16-24 subjects in Part D, and 8-12 subjects in optional Part E), including both males and females, will be enrolled in the phase I study.
This study will include Five parts: SSD8432 single dose and SSD8432 co-administrated with ritonavir (Part A), SSD8432 multiple dose (Part B), SSD8432 co-administrated with ritonavir multiple dose (Part C), SSD8432 co-administered ritonavir single dose in fasting and postprandial states (Part D: assessment of food effects) and optional part (Part E: Assessment of the safety and pharmacokinetics of SSD8432 in white healthy adult 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male subjects' weight ≥ 50 kg, female subjects' weight ≥ 45 kg; body mass index ≥ 19 kg/m2 and ≤ 28 kg/m
- •Female participants of child-bearing potential must agree to use adequate contraception from screening until 1 months after last dose.
排除标准
- •History of any other acute or chronic illness (including cardiovascular, pulmonary, neurological, hepatic, rheumatic, hematological, metabolic or renal disorders), or use of medication that, in the opinion of the Principal Investigator, may not suitable for participating in this study.
- •Subjects with a history of hematophobia or trypanophobia and unable to tolerate intravenous indwelling needle blood sampling.
- •History of dysphagia or any other gastrointestinal disease possibly affecting drug absorption.
- •Take special diet and cannot abide by the provided food and corresponding requirements in this study.
- •Subject with a history of clinically significant hypersensitivity reactions to the active substance of SSD8432 or ritonavir or to any other components of drug products.
研究组 & 干预措施
SSD8432 dose 1~7
Dose level 1 ~7 of SSD8432
干预措施: SSD8432 dose 1~7 and Ritonavir (Drug)
SSD8432 dose 8~9
Dose level 8 ~9 of SSD8432
干预措施: SSD8432 dose 8~9 (Drug)
SSD8432 dose 10~12
Dose level 10 ~12 of SSD8432
干预措施: SSD8432 dose 10~12 and ritonavir (Drug)
SSD8432 dose 13
Dose level 13 of SSD8432
干预措施: SSD8432 dose 13 and Ritonavir (Drug)
SSD8432 dose 14
Dose level 14 of SSD8432
干预措施: SSD8432 dose 14 and Ritonavir (Drug)
结局指标
主要结局
The Adverse events of SSD8432(Part A~D)
时间窗: From signing ICF up to day 26
Adverse events, including type, incidence, grade (determined with reference to NCI-CTCAE V5.0)
PK parameters(Part E)
时间窗: Day 1 to Day 4
Time for Cmax (Tmax)
次要结局
- PK parameters(Part A~D)(Day 1 to Day 4)
- The Adverse events of SSD8432(Part E)(From signing ICF up to day 26)