Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SPARC1316
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Number of Subjects With Adverse Events
研究概览
简要总结
Sun Pharma Advanced Research company Limited has developed a dry powder inhaler of compound SPARC1316 for oral inhalation. This clinical study is a Phase I/IIa study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple ascending doses of S0597 administered by oral inhalation to healthy volunteers and asthma patients.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects willing to provide informed consent
- •Male or female subjects aged 18 to 65 years inclusive
- •Body mass index (BMI) between 18.0 and 30.0 kg/m2 inclusive
- •Non-smokers or ex-smokers
排除标准
- •Subjects with a supine systolic blood pressure ≥160 mmHg and/or a supine diastolic blood pressure ≥100 mmHg
- •Subjects who have a significant infection or known inflammatory process on screening or admission.
- •Subjects who are unlikely to co-operate with the requirements of the study.
- •Positive serology for infectious disease (hepatitisB or C , HIV) at screening
研究组 & 干预措施
SPARC1316 Dose 1
Subjects will be administered with SPARC1316 dose 1
干预措施: SPARC1316 Dose 1 (Drug)
Placebo
The subjects will receive placebo.
干预措施: Placebo (Drug)
SPARC1316 Dose 2
Subjects will be administered with SPARC1316 dose 2
干预措施: SPARC1316 Dose 2 (Drug)
SPARC1316 Dose 3
Subjects will be administered with SPARC1316 dose 3
干预措施: SPARC1316 Dose 3 (Drug)
SPARC1316 Dose 4
Subjects will be administered with SPARC1316 dose 4
干预措施: SPARC1316 Dose 4 (Drug)
SPARC1316 Dose 5
Subjects will be administered with SPARC1316 dose 5
干预措施: SPARC1316 Dose 5 (Drug)
结局指标
主要结局
Number of Subjects With Adverse Events
时间窗: Two (2) Weeks
The no of adverse events will be assessed to evaluate the safety and tolerability of compound SO597 in healthy male subjects and asthma patients
次要结局
未报告次要终点