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:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2025-12-25 @ 3:32 AM
NCT ID:
NCT04488705
Eligibility Criteria:
Inclusion Criteria:
* Males \& females using suitable methods of contraception or females of non-childbearing potential
* Consent to study participation
* Body weight ≥ 50 kg and body mass index within the range 19 - 30 kg/m2
* Vital signs assessments within normal ranges
* Healthy as determined following physical examination at screening visit
* Spirometry readings (FEV1 and FVC) to be ≥ 80% of predicted value
Exclusion Criteria:
* Acute or chronic illness detected at screening visit
* Respiratory tract infection within 4 weeks of the screening visit
* Use of prescription or OTC medication within 14 days of the screening visit
* History of regular alcohol consumption over recommended limits within 6 months of the study, or history/evidence of alcohol or drug abuse
* Smoking or use of tobacco products within 6 months of screening
* Abnormal blood/urine laboratory screening test results
* Current, or history of, allergy that may be contraindicated
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT04488705
Study Brief:
Protocol Section:
NCT04488705