NCT07331402进行中（未招募）2 期
A Random, Single Blind, Positive Control, Crossover Design Clinical Study to Evaluate the Pharmacokinetics and Pharmacodynamics of HSK39004 Inhalation Suspension in COPD Patients
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- The Cmax after single administrations
研究概览
简要总结
This is a random, single blind, positive control, crossover design clinical study to evaluate the pharmacokinetics and pharmacodynamics of HSK39004 inhalation suspension in COPD patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •During the screening visit (Visit 1), the age range is 40 to 80 years (including the threshold value), and gender is not restricted;
- •The subjects with chronic obstructive pulmonary disease (COPD) as per the GOLD 2025 diagnostic criteria, and the symptoms before screening were consistent with COPD for at least 1 year [GOLD 2025 standard: the subjects have chronic respiratory symptoms such as shortness of breath, chronic cough or expectoration, and/or have a history of exposure to risk factors, and the pulmonary function test results show: the forced expiratory volume in one second (FEV1) after using bronchodilators / forced vital capacity (FVC) <0.7];
- •During the screening visit (Visit 1):· FEV1/FVC after using bronchodilators is <0.7;· 30% of the expected value ≤ FEV1 after using bronchodilators < 80% of the expected value;
- •COPD stable within 4 weeks prior to screening period (Visit 1);
- •During the screening period and treatment period, COPD drugs prohibited by the protocol (except for salbutamol inhalation aerosol as a rescue drug) can be discontinued;
- •Current smokers with a smoking quantity of ≥ 10 packs per year (smoking index (pack years) = daily smoking quantity (packs) × time (years), 1 pack = 20 cigarettes), or quit smoking for more than 6 months, or those with a history of exposure to other risk factors;
- •Participants voluntarily sign the informed consent form；
排除标准
- •Have a history of life-threatening COPD, including being admitted to the intensive care unit and/or requiring intubation;
- •Have received treatment for COPD acute exacerbation for pneumonia within 12 weeks before screening;
- •Have a history of or currently have severe cardiovascular diseases;
- •Have type I diabetes or poorly controlled type II diabetes (fasting blood glucose ≥ 10 mmol/L at screening);
- •Have cancer (in situ cancer that has been cured for more than 5 years, skin squamous cell carcinoma and basal cell carcinoma, etc., except for subjects with suspected malignant tumors or undetermined tumors);
- •Combine other severe unstable kidney, nervous system, endocrine diseases, thyroid diseases, urinary system, ophthalmic diseases, immune system, mental system, gastrointestinal, liver or blood system disease/abnormal history, as determined by the investigator, participation in this study may pose risks to the subjects or affect the analysis of research results;
- •During the screening period (visit 1), the investigator determines that the laboratory tests of the subjects show clinically significant abnormalities that may pose risks to the subjects;
- •Allergy to HSK39004 inhalation powder or salbutamol or any known components in the administration system ;
- •Before the pulmonary function test during the screening (visit 1), any prohibited drugs in the protocol were used;
- •During the screening period, there were clinically significant abnormalities in the 12 lead electrocardiogram that were determined by the researchers to be potentially risky for the subjects;
- •Had major surgery (requiring general anesthesia) within 6 weeks before screening, not fully recovered at the time of screening, or planned to undergo surgery before the end of the study;
- •Pregnant or lactating women, or female subjects with positive pregnancy test results;
- •Researchers determine other subjects who are not suitable to participate.
研究组 & 干预措施
HSK39004- Ohtuvayre
Experimental
The first period, HSK39004 inhalation suspension , Inhale through the mouth, 3mg each time, twice a day; The second period，Ohtuvayre inhalation suspension, Inhale through the mouth, 3mg each time, twice a day
干预措施: HSK39004 inhalation suspension (Drug)
Ohtuvayre - HSK39004
Other
The first period，Ohtuvayre inhalation suspension, Inhale through the mouth, 3mg each time, twice a day; The second period，HSK39004 inhalation suspension , Inhale through the mouth, 3mg each time, twice a day.
干预措施: HSK39004 inhalation suspension (Drug)
结局指标
主要结局
The Cmax after single administrations
时间窗: [Time Frame: From the start of administration to 12 hours post-dose]
The Cmax of HSK39004 in plasma
The Css(max) after multiple administrations (steady state)
时间窗: [Time Frame: From the start of administration to 7 days post-dose]
The Css(max) of HSK39004 in plasma
次要结局
- The ΔFEV1 AUC0-12h([Time Frame: From the start of administration to 12 hours post-dose on Day1 and Day7])
- AEs([Time Frame: From the time of signing ICF to the end of follow-up，up to 7 days after the last administration])
研究者
研究点 (1)
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