NCT06971198已完成1 期
Phase I Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of HSK39004 Dry Powder Inhalation
Haisco Pharmaceutical Group Co., Ltd.1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2025年2月10日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- adverse events
研究概览
简要总结
To evaluate the safety, tolerability and pharmacokinetic characteristics of HSK39004 dry powder inhalation 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
- Single (Participant)
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
- •Voluntarily sign the informed consent form, understand the trialprocedures, and be willing to comply with all trial procedures andrestrictions;
- •18 years to 45 years (inclusive), male and female;
- •Male subjects weight ≥50 kg and female subjects weight ≥45 kg. Body mass index (BMI) : 18-26 kg/m2 (inclusive) ;
- •Normal lung function during the screening period, no airway obstruction, FEV1 and forced vital capacity(FVC) are at least 80% of the predicted values;
- •Never smoked or have quit smoking for ≥ 12 months and have a previous smoking history of < 5 pack per years;
- •Subjects are willing to voluntarily use effectivecontraceptives from screening to at least 3 months after the last dose administration.
排除标准
- •Have a history of severe and uncontrolled diseases, such ascardiovascular, respiratory, liver, gastrointestinal, endocrine,hematologic, mental/nervous systems diseases within 3 months prior to screening;
- •Have a history of any malignant tumors;
- •Normal or abnormal vital signs, physical examination, laboratory examination, electrocardiogram, and imageological examination have no clinical significance;
- •Previous or current gastrointestinal, liver, kidney, or other disease known to interfere with drug absorption, distribution, metabolism, or excretion;
- •Acute respiratory infections occurred within 6 weeks before screening and/or before randomization;
- •Have a history of high consumption of grapefruit juice, methylxanthinerich food or beverage within 48 hours before the administration;
- •Average alcohol intake is more than 14 unit per week (1unit=10g alcohol , 1 unit=285 mL 4.9% alcohol beer, or 30 mL 40% alcohol spirit, or 100mL 12% alcohol wine) within the 3 months prior to screening;
- •Have a history of drug abuse prior to screening, or positive urine drug screen at screening;
- •Blood donation (or blood loss) ≥400 mL within 3 months prior to the screening;
- •Subjects who have a allergic to any component of HSK39004 or allergic history;
- •Subjects who use any live vaccine within 30 days prior to screening;
- •Have participated in any clinical investigator within 3 months prior to screening;
- •A pregnant/lactating woman, or has a positive pregnancy test at screening or during the trial;
- •Not suitable for this study as judged by the investigator.
研究组 & 干预措施
HSK39004
Experimental
干预措施: HSK39004 (Drug)
Placebo
Placebo Comparator
Placebo group
干预措施: Placebo (Drug)
结局指标
主要结局
adverse events
时间窗: From the enrollment of the subjects to 72 hours after the last administration
次要结局
- AUC(from 0 to 72 hours after administration)
- Cmax(from 0 to 72 hours after administration)
- t1/2(from 0 to 72 hours after administration)
- Vz/F(from 0 to 72 hours after administration)
- CL/F(from 0 to 72 hours after administration)
研究者
研究点 (1)
Loading locations...
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