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 @ 9:44 PM
Ignite Modification Date:
2025-12-24 @ 9:44 PM
NCT ID:
NCT03959332
Eligibility Criteria:
Inclusion Criteria:
* Chinese participants must have Chinese parents and grandparents, all of whom were born in China.
* Healthy status as defined by absence of evidence of any active or chronic disease
* Participants whose body weight is ≥50 to \<80 kg and body mass index is ≥18.5 to \<26 kg/m2
Exclusion Criteria:
* Participants with a history of stomach, vagus nerve, or intestinal surgery (except for appendectomy)
* Participants who have a history of allergic symptoms including food allergy (Note: Non-active allergic rhinitis will be allowed)
* Participants who require chronic drug therapy or those who have used drugs within 3 days prior to screening or within 14 days prior to Day -1
* Participants who have used alcohol-containing, caffeine-containing, grapefruit containing, or St. John's wort-containing products within 72 hours prior to Day -1
* Participants who have used tobacco- or nicotine-containing products within 24 weeks prior to screening
* Participants who have donated \> 400 mL of blood within 12 weeks or \> 200 mL of blood within 4 weeks prior to screening, or have donated any amount of blood between screening and Day -1
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
59 Years
Study:
NCT03959332
Study Brief:
Protocol Section:
NCT03959332