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 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 1:33 AM
NCT ID:
NCT03630094
Eligibility Criteria:
Inclusion Criteria:
* Body mass index (BMI) greater than or equal to18.5 and less than or equal to 30 (kg per m2) and weight between 55.0 and 100.0 kg (both inclusive).
* Medical history without any major pathology as judged by the Investigator.
* Forced expiratory volume in 1 second (FEV1) of at least 70% of predicted value at screening.
Exclusion Criteria:
* History or presence of significant oncologic, cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal,endocrine, immunologic, dermatologic, neurological, or psychiatric disease.
* Positive alcohol breath test or urine drug screen test at screening or confinement.
* Current use or has used tobacco or nicotine containing products 6 month prior to screening.
* Positive testing for HIV, Hepatitis B or Hepatitis C.
* History or presence of alcohol or drug abuse within the 2 years prior to screening.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT03630094
Study Brief:
Protocol Section:
NCT03630094