NCT07567872招募中1 期
A Phase I Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HRS-9821 Powder for Inhalation Administered as a Single Dose in Healthy Participants and Multiple Doses in Patients With COPD
Guangdong Hengrui Pharmaceutical Co., Ltd1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2026年7月9日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 48
- 试验地点
- 1
研究概览
简要总结
The aim of this study was to evaluate the safety and tolerability of HRS-9821 Powder for Inhalation administered in a single dose in healthy individuals and multiple doses in patients with COPD。
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Informed consent was obtained to participate in the trial
- •Body weight ≥45 kg,and BMI 18-33 kg/m2 (both ends included)
- •The 12-lead ECG was normal or abnormal but clinically insignificant until randomization
- •Contraception was strict from the time informed consent was signed until 1 month (for subjects receiving HRS-9821/ placebo) or 3 months (for male subjects receiving moxifloxacin) after the last dose
- •All study regulations and procedures were followed and inhalation devices used in the study were used correctly during the study
- •The following inclusion criteria apply only to healthy subjects:
- •Vital signs were normal at screening
- •Pulmonary function was normal during screening
- •No smoking or smoking cessation ≥12 months before screening, and previous smoking history <5 pack-years；
- •Healthy male 18-50 years old
- •The following inclusion criteria apply only to subjects with COPD
- •Male or female, aged 40-75 years;
- •Patients diagnosed with COPD;
- •A post-bronchodilator FEV1 /FVC < 0.7,40% ≤FEV1 < 80% of the predicted value,;
- •Smoking history of≥ 10 pack-years;
- •Normal chest X-ray examination results at screening;
- •Supporting discontinuation of COPD-related medications before randomization；
排除标准
- •Mean QTcF ≥ 450 ms at screening；
- •Persons who had donated blood or had massive blood loss (> 400 ml) within 4 weeks before screening or who were interested in donating blood during the study
- •Receipt of the investigational drug or device within 4 weeks before randomization or less than 5 times the half-life of the drug, whichever was greater;
- •Patients who had difficulty in blood collection or could not tolerate venipuncture in the past, such as dizzy with needles or blood
- •History of malignancy in any organ system
- •Known allergies to salbutamol, study medication, or any excipients in the formulation
- •Known previous infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV); Or positive HIV (according to a trial-site SOP), treponema pallidum antibody, HBV surface antigen, or HCV antibody before randomization
- •History of alcohol abuse
- •History of drug abuse and drug dependence in the past 5 years；
- •Positive for alcohol or substance abuse test before randomization
- •During the study, surgery or treatment that might interfere with the conduct of the study was planned；
- •Unable or unwilling to fully adhere to the study protocol
- •Mentally or legally incapacitated
- •There were any other reasons for the subject not to participate in the study in the opinion of the investigator;
- •Use of a strong/moderate potency drug that inhibits or induces the hepatic drug-metabolizing enzyme CYP3A4 14 days before the first dose;
- •Drugs with effects on P-glycoprotein (P-gp) or breast cancer resistance protein (BCRP) were anticipated to be used during the study;
- •History of using HRS-9821 suspension;
- •The following exclusion criteria apply only to healthy subjects:
- •Have been treated with antibiotics for upper and lower respiratory tract infections within 12 weeks prior to screening;
- •Abnormal laboratory or physical examination results with clinical significance;
- •Positive urine nicotine test before randomization;
- •Have consumed a prescription within 14 days prior to the first dose or over-the-counter drugs within 48 h prior to the first dose;
- •The following exclusion criteria apply only to subjects with COPD
- •History of life-threatening acute exacerbation of COPD (AECOPD), including admission to intensive care unit and/or need for invasive ventilator support;
- •Diagnosed with other respiratory disorders;
- •Pulmonary heart disease, or pulmonary hypertension caused by lung disease and/or hypoxia;
- •History of lung volume reduction surgery, partial lung resection, lung transplantation, and other surgeries that may affect pulmonary function results;
- •History of AECOPD requiring systemic glucocorticoids or antibiotics or hospitalization within 4 weeks prior to screening;
- •Lower respiratory tract infection requiring antibiotic treatment within 4 weeks prior to screening;
- •Requiring oxygen therapy or home non-invasive ventilation;
- •Currently using or plan to use non-selective beta blockers or other drugs with bronchoconstrictive effects during the study;
- •Patients with serious trauma or major surgery within 6 months prior to screening who are still in the recovery period;
- •Abnormal laboratory tests at screening and baseline.
研究组 & 干预措施
placebo for HRS-9821 Powder Inhalation
Placebo Comparator
Participants received a single dose or 12 consecutive days of placebo for HRS-9821 Powder Inhalation with HRS-9821.
干预措施: Placebo (Drug)
HRS-9821 Powder for Inhalation
Experimental
Participants inhaled HRS-9821 powder either as a single dose or for 12 days.
干预措施: HRS-9821 Powder for Inhalation (Drug)
研究者
研究点 (1)
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