Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:57 PM
Ignite Modification Date:
2025-12-24 @ 7:57 PM
NCT ID:
NCT03182504
Eligibility Criteria:
Inclusion Criteria:
* 18 to 60 years of age, inclusive
* Healthy, as judged by the Investigator and defined by the absence of evidence of any active or clinically significant chronic disease identified from a detailed medical and surgical history, physical examination including vital signs and 12-lead electrocardiogram (ECG), and laboratory safety test results
* Body mass index (BMI) within the range 18-30 kilogram per square meter (kg/m\^2),inclusive
* Non-smoker, or former smoker who has abstained from smoking for at least 6 months
* Negative pregnancy test and agreement to comply with measures to prevent pregnancy in women
* Refrain from sperm donation and agreement to comply with measures to prevent pregnancy in partner of childbearing potential for men
Exclusion Criteria:
* History of asthma or clinically significant lung disease
* Any condition which contraindicates a BAL procedure
* History of clinically significant gastrointestinal, renal, hepatic, broncho-pulmonary, neurological, psychiatric, cardiovascular, endocrinological, hematological, dermatological, immunological or allergic disease, metabolic disorder, cancer or cirrhosis
* Clinically significant change in health status, as judged by the Investigator, or any major illness within the four weeks before screening, or clinically significant acute infection or febrile illness within the 14 days before screening
* History of epilepsy (or known seizure disorder), brain lesions or other significant neurological disorders
* Participation in any other clinical study involving an investigational medicinal product or device within 3 months before screening
* Known history of clinically significant hypersensitivity or urticaria, or severe allergic reaction to any drug, in particular antibiotics
* Donation or loss of over 500 milliliter (mL) of blood within the three months before screening
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT03182504
Study Brief:
Protocol Section:
NCT03182504