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 aged 39 to 69 years old (inclusive)
• Women who are not pregnant or breastfeeding, and who are either unable to have children, or who are willing to use an acceptable form of contraception from the screening stage until 30 days after the last dose of the study treatment
• Women who could potentially become pregnant must have a negative pregnancy test at the screening stage and on the first day of treatment
• Men who agree to avoid donating semen and to either abstain from heterosexual intercourse or use a condom, during the study and for at least 30 days after the last dose of study treatment
• People who have been diagnosed with mild or moderate COPD caused by cigarette smoking, or by exposure to biomass burning or pollution, according to 2023 international guidelines (confirmed by a breathing test after using a bronchodilator)
• People who have previously received treatment for their COPD
• People whose COPD has been stable — meaning no flare-ups, no hospital stays, and no changes to COPD medication in the weeks before the screening stage (confirm specific timeframes with trial site)
• People who agree not to smoke during the treatment and follow-up periods of the study
• People who are willing and able to sign a written consent form

Who may not be able to join:

• People who have, or have previously had, certain other types of COPD (classified as COPD-G, COPD-D, COPD-I, COPD-A or COPD-U), or other lung or heart conditions such as asthma, heart failure, bronchiectasis, tuberculosis, or certain other airway diseases
• People who have, or have previously had, breathing failure caused by a condition other than COPD, such as pulmonary fibrosis, cystic fibrosis, sarcoidosis, or certain other lung diseases — including if any of these are found during screening scans
• People who had severe breathing failure related to a COVID-19 lung infection in the 12 weeks before screening
• People who are currently using, or have used in the past 21 days, steroid tablets or injections (note: inhaled steroids may be permitted under certain conditions — confirm with trial site)
• People with a history of chronic liver disease, or abnormal liver blood test results at screening (people with a condition called Gilbert's syndrome may still be eligible — confirm with trial site)
• People with a history of chronic kidney disease, or reduced kidney function detected at screening (confirm specific measurements with trial site)
• People with high blood pressure that is not controlled, or that requires more than two medications to control
• People with a recent history (within the past two years) of heart disease, heart surgery, stroke, or significant blood vessel disease
• People with Type 1 or Type 2 diabetes where blood sugar control has not been adequate, as shown by a specific blood test result at screening
• People who have had an active cancer diagnosis in the past three years, or in whom a potential growth is detected during screening scans (people with a history of certain common skin cancers may still be eligible — confirm with trial site)
• People with a history of HIV, Hepatitis B, Hepatitis C, or other conditions that weaken the immune system, or who have used immune-suppressing medications recently
• People who have had an active infection requiring antibiotic treatment in the 12 weeks before screening
• People with a body mass index (a measure of body weight relative to height) above 60
• People who have smoked tobacco, cannabis, or used a vaping device in the 28 days before screening, as confirmed by a urine test (nicotine replacement products such as patches or gum are permitted)
• People with a history of alcohol or substance misuse where sobriety has been less than one year, or where the trial doctor believes it may affect participation
• People who are pregnant or breastfeeding
• People with a severe allergy to any medication, including allergies to beef-derived (bovine) products
• People with any other medical or mental health condition that the trial doctor believes may make it unsafe to participate or difficult to complete the study
• People who are currently in another clinical trial, who have participated in one in the past six weeks, or who have received an experimental treatment within the past 12 months
• People who are unable or unwilling to follow the study schedule and procedures

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