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 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 12:32 AM
NCT ID:
NCT03075267
Eligibility Criteria:
Inclusion Criteria:
* Male and female Chinese subjects 18-45 years of age
* Females of childbearing potential must agree to be abstinent or else use one of the medically acceptable forms of contraception A female whose male partner has had a vasectomy must agree to use one additional form of medically acceptable contraception.
A male subject with female partner of child bearing potential must agree to use one additional form of medically acceptable contraception
-Be in good general health as assessed at Screening and have no clinically significant abnormal labs at Screening.
Exclusion Criteria:
* Pregnant or nursing female subjects or subjects who are trying to conceive
* Subjects with clinically significant neurologic, cardiovascular, hepatic, renal, endocrinologic, pulmonary, hematological, psychiatric, or other medical illness that would interfere with participation in this study
* Subjects with a history of ECG abnormalities
* Subjects who have cancer that has not been in complete remission for at least 5 years
* Male subjects with symptomatic prostatic hypertrophy that is clinically significant in the opinion of the Investigator
* Male subjects with a trans-urethral resection of the prostate or full resection of the prostate within 6 months prior to Screening
* Males with bladder neck obstruction or urinary retention that is clinically significant in the opinion of the Investigator
* Subjects with a diagnosis of glaucoma that in the opinion of the Investigator has not been adequately treated
* History of substance-related disorders within 1 year of Screening
* History of smoking or the use of nicotine containing products or electronic cigarettes within 3 months of Screening by self-reporting
* A positive alcohol breathalyzer or urine drug screen for drugs of abuse at the Screening Visit or at the beginning of each inpatient period
* Treatment with any prescription or non-prescription drugs (including vitamins, herbal, and dietary supplements) within 30 days
* Positivity for human immunodeficiency virus (HIV) or Hepatitis B surface antigen (HbsAg) or positive hepatitis C antibody at Screening
* Positive for Syphilis Antibody
* Subjects with any flu-like syndrome or other respiratory infections
* Recently vaccinated with an attenuated live virus
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT03075267
Study Brief:
Protocol Section:
NCT03075267