Phase 1 COPD Trial, Recruiting

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

Who might be able to join this trial:

• People who have given their written agreement to take part in the trial
• People who weigh at least 45 kg and have a body mass index (BMI) between 18 and 33
• People whose heart rhythm test (ECG) results are normal or only slightly abnormal in a way that is not medically concerning
• People who are willing to use reliable contraception from the time of signing consent until at least 1 month after the last dose (or 3 months for male participants receiving moxifloxacin)
• People who are willing and able to follow all study rules and correctly use the inhalation devices provided

For healthy participants only:

• People with normal vital signs (such as blood pressure and heart rate) at the initial screening visit
• People with normal lung function at screening
• People who have never smoked, or who stopped smoking at least 12 months before screening and have a limited lifetime smoking history (fewer than 5 pack-years)
• Healthy males between 18 and 50 years old

For participants with COPD only:

• Males or females between 40 and 75 years old
• People who have been diagnosed with COPD
• People whose lung function test results show a specific pattern consistent with moderate COPD (confirm with trial site for exact figures)
• People with a smoking history of at least 10 pack-years
• People with a normal chest X-ray at screening
• People who are willing to stop taking their usual COPD medications before the trial begins

Who may not be able to join:

• People whose heart rhythm test shows a certain type of electrical interval (QTcF) averaging 450 milliseconds or more at screening
• People who have donated blood or lost more than 400 ml of blood in the 4 weeks before screening, or who plan to donate blood during the study
• People who have taken part in another clinical trial or used an experimental treatment within 4 weeks before joining (or within a longer period depending on the drug used)
• People who have had difficulty with blood draws in the past, such as fainting at the sight of needles or blood
• People with a history of cancer in any part of the body
• People with known allergies to salbutamol, the study medication, or any of its ingredients
• People with a known history of HIV, hepatitis B, or hepatitis C, or who test positive for these or related infections before joining
• People with a history of alcohol misuse
• People with a history of drug misuse or dependency in the past 5 years
• People who test positive for alcohol or drug use before joining
• People who have planned surgery or medical treatment during the study that could interfere with the trial
• People who are unable or unwilling to follow the study rules
• People who lack the mental or legal capacity to consent
• People for whom the investigator has any other concern about participation
• People who have used certain medications that affect how the liver breaks down drugs (strong or moderate CYP3A4 inhibitors or inducers) in the 14 days before the first dose
• People who are expected to use medications that affect certain drug transport proteins (P-gp or BCRP) during the study
• People who have previously used HRS-9821 suspension

For healthy participants only:

• People who have been treated with antibiotics for a respiratory tract infection within 12 weeks before screening
• People with laboratory or physical examination results that are abnormal in a clinically significant way
• People who test positive for nicotine use before joining
• People who have taken prescription medications in the 14 days before the first dose, or over-the-counter medications in the 48 hours before the first dose

For participants with COPD only:

• People who have had a life-threatening COPD flare-up, including admission to intensive care or the need for a breathing machine
• People diagnosed with other lung or breathing conditions
• People with heart or blood pressure problems caused by their lung disease or low oxygen levels
• People who have had lung surgery such as lung volume reduction, partial lung removal, or a lung transplant
• People who have had a COPD flare-up requiring steroids, antibiotics, or hospitalisation within 4 weeks before screening
• People who have had a lower respiratory tract infection requiring antibiotics within 4 weeks before screening
• People who currently require supplemental oxygen or home breathing support (non-invasive ventilation)
• People who are currently using, or plan to use, certain medications that can cause the airways to narrow (such as non-selective beta blockers)
• People who are still recovering from a serious injury or major surgery within the past 6 months
• People with abnormal blood test results at screening or at the start of the trial

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