NCT05622864已完成1 期
Phase I Study on the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Dose Escalation of Nebulized Inhalation of HRS-9821 Suspension in Healthy Individuals and Multiple Doses in COPD Patients
Guangdong Hengrui Pharmaceutical Co., Ltd1 个研究点 分布在 1 个国家目标入组 106 人开始时间: 2023年1月12日最近更新:
适应症
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
- 106
- 试验地点
- 1
- 主要终点
- Assess the incidence and severity of adverse events after single atomization inhalation of HRS-9821 in healthy subjects and multiple atomization inhalation of HRS-9821 in COPD patients.
研究概览
简要总结
The increased safety and tolerance of single and multiple atomized inhalation of HRS-9821 suspension for inhalation doses in healthy subjects and COPD 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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Sign an informed consent forms；
- •Healthy men aged 18-50 (both ends, subject to the signing of the informed consent form); COPD patients aged 40-75 (both ends, subject to the signing of the informed consent form);
- •Weight ≥45 kg，BMI 18-33 kg/m2 (include 33 kg/m2);
- •During the screening period, the vital signs of healthy subjects are normal:
- •Shrinkage 90-140 mmHg,
- •diastolic pressure 50-90 mmHg,
- •Heart rate 40-100 times/min;
- •During the screening period, the lung function of healthy subjects is normal, that is, the predicted value of FEV1≥80% and the predicted value of FEV1/FVC≥92%; After COPD patients inhale bronchodilators, he predicted value of FEV1≥40% and the predicted value of FEV1/FVC<0.7;
- •During screening, the 12-lead ECG is normal or abnormal but has no clinical significance.
- •Follow the contraceptive requirements within 14 weeks from the beginning of the consent to the last dose, and do not donate sperm during the consent period;
- •During the study, all research regulations and procedures can be followed, and the atomization devices used by the research institute can be used correctly;
- •Healthy subjects: non-smoking or quitting smoking ≥ 12 months, the previous smoking history < 5 packs of years; COPD patients: the previous smoking history ≥ 10 packs of years.
排除标准
- •Healthy subjects: in the past 12 weeks, antibiotics have been used for upper and lower respiratory tract infections, or have a history of respiratory infections within the past 4 weeks; COPD patients: in the past 4 weeks, antibiotics have been used for lower respiratory tract infections;
- •Healthy subjects: abnormal laboratory or physical examination results of clinical significance;
- •The average value of QTcF for 3 times at screening is ≥450ms;
- •In the past four weeks, there have been blood donations or large blood loss (more than 400 milliliters), or those who intentionally donate blood during the study;
- •Accept experimental drugs or use experimental medical devices within 1 months or less than 5 times the half-life of the drug, whichever is longer;
- •In the past, there were difficulties in collecting blood or could not withstand intravenous puncture, such as needle halo and blood halo
- •Any organ system has a history of malignant tumors;
- •Known to be allergic to any accessories in the research drug or formulation;
- •Previously known infection of human immunodeficiency virus (HIV), hepatitis B virus (HBV) liver or hepatitis C virus (HCV); or randomized pre-HIV (according to the test center SOP), treponema pallidum antibody (TPPA), HBV surface antigen or HCV antibody positive;
- •There is a history of smoking and alcoholism in the 3 months before screening: smoking (more than 5 cigarettes or equivalent tobacco per day); alcoholism (more than 14 units of alcohol per week: 1 unit = 360 mL of beer, or 25 mL of spirits with a concentration of 40% or more, or 1 glass of wine, 180mL);
- •In the past five years, there has been a history of drug abuse and drug dependence;
- •Before randomization, positive for alcohol or drug abuse or nicotine in urine;
- •During the study, there is a surgical plan or may interfere with the treatment plan carried out by the study;
- •Inability or unwillingness to fully comply with the research program;
- •Mentally or legally incapacitated;
- •The researchers believe that there are any other reasons why the subjects are unfit to participate in the study;
- •Prescription was used within 14 days before the first administration or within 48 hours before the first administration;
- •Drugs that have used strong/intermediate inhibitors or induce liver drug metabolic enzyme CYP3A4 14 days before the first administration or ingest grapefruit or related products within 7 days before the first administration;
- •During the study, it was expected to use drugs that had an effect on P-gp or breast cancer drug-resistant protein (BCRP).
研究组 & 干预措施
Part A
Experimental
干预措施: HRS-9821 (Drug)
Part B
Experimental
干预措施: HRS-9821 (Drug)
结局指标
主要结局
Assess the incidence and severity of adverse events after single atomization inhalation of HRS-9821 in healthy subjects and multiple atomization inhalation of HRS-9821 in COPD patients.
时间窗: About a month from the first medication to the evaluation.
次要结局
- Evaluate the forced expiratory volume in one second (FEV1) after single atomization inhalation of HRS-9821 in healthy subjects and multiple atomization inhalation of HRS-9821 in COPD patients.(24 hours after the first dose)
- Evaluate the average value of FEV1 compared with baseline changes after single atomization inhalation of HRS-9821 in healthy subjects and multiple atomization inhalation of HRS-9821 in COPD patients.(24 hours after the first dose)
- Evaluate the change of FEV1 peak after single atomization inhalation of HRS-9821 in healthy subjects and multiple atomization inhalation of HRS-9821 in COPD patients.(About 24 hours after the first dose)
- Evaluate the force lung capacity (FVC) after single atomization inhalation of HRS-9821 in healthy subjects and multiple atomization inhalation of HRS-9821 in COPD patients.(2 hours after the first dose)
- Evaluate pharmacokinetics concentration and pharmacokinetic parameters of after single atomization inhalation of HRS-9821 in healthy subjects and multiple atomization inhalation of HRS-9821 in COPD patients.(2 weeks after the first dose)
研究者
研究点 (1)
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