Phase 1 COPD Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

For all participants:

• Consent to take part in the trial has been given
• Body weight is at least 45 kg and BMI is between 18 and 33 kg/m²
• Heart tracing (ECG) results are normal, or only show minor changes that are not considered medically significant
• Strict contraception is used from the time of signing consent until 1 month after the last dose (for those receiving HRS-9821 or placebo) or 3 months after the last dose (for male participants receiving moxifloxacin)
• All study rules and procedures are followed, including correct use of any inhalation devices provided

For healthy participants only:

• Vital signs (such as heart rate and blood pressure) are normal at the screening visit
• Lung function test results are normal at the screening visit
• A person has not smoked for at least 12 months before screening, and their total lifetime smoking history is less than 5 pack-years
• Healthy males aged 18 to 50 years

For people with COPD only:

• Male or female, aged 40 to 75 years
• A formal diagnosis of COPD has been made
• Specific lung function test results meet the required levels — FEV1/FVC below 0.7 and FEV1 between 40% and 80% of the expected value (confirm with trial site)
• A smoking history of at least 10 pack-years
• Chest X-ray results are normal at the screening visit
• Willingness to stop taking certain COPD-related medications before the study begins

Who may not be able to join:

For all participants:

• A heart measure called QTcF is 450 milliseconds or higher at screening
• Blood has been donated, or more than 400 ml of blood was lost, within 4 weeks before screening, or there are plans to donate blood during the study
• Another investigational drug or device has been used within 4 weeks before joining, or within 5 times the elimination period of that drug — whichever is longer
• There is a history of difficulty with blood draws, such as needle phobia or fainting at the sight of blood
• There is a history of cancer in any part of the body
• There is a known allergy to salbutamol, the study drug, or any of its ingredients
• There is a known history of HIV, hepatitis B, or hepatitis C infection, or a positive test result for any of these before joining
• There is a history of alcohol misuse
• There is a history of drug misuse or drug dependence in the past 5 years
• An alcohol or drug test comes back positive before the study begins
• Surgery or other treatment that could interfere with the study is planned during the study period
• A person is unwilling or unable to follow the study procedures
• A person is unable to make their own informed decisions due to mental or legal incapacity
• The investigator has any other reason to consider a person unsuitable for the study
• Certain medications that affect a liver enzyme called CYP3A4 have been taken within 14 days before the first dose (confirm with trial site)
• Certain medications that affect proteins called P-gp or BCRP are expected to be used during the study (confirm with trial site)
• There is a history of using the study drug HRS-9821 suspension previously

For healthy participants only:

• Antibiotics were taken for a respiratory infection within 12 weeks before screening
• Blood tests or physical examination results show clinically significant abnormalities
• A urine test for nicotine comes back positive before the study begins
• Prescription medications have been taken within 14 days before the first dose, or over-the-counter medications within 48 hours before the first dose

For people with COPD only:

• There is a history of a severe COPD flare-up that required intensive care or a breathing machine
• Another respiratory condition has also been diagnosed
• There is a history of pulmonary heart disease or high blood pressure in the lungs caused by lung disease or low oxygen levels
• There is a history of lung surgery such as lung volume reduction, partial lung removal, or lung transplant
• A COPD flare-up requiring steroids, antibiotics, or hospitalisation has occurred within 4 weeks before screening
• A lower respiratory tract infection requiring antibiotics has occurred within 4 weeks before screening
• Ongoing oxygen therapy or home breathing machine support is required
• Non-selective beta-blocker medications or other drugs that can cause airway narrowing are currently being used or planned for use during the study
• Recovery from a serious injury or major surgery within the past 6 months is still ongoing
• Blood test results at screening and the start of the study are abnormal

Important: Always verify eligibility with the trial site directly before applying.