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 @ 11:25 PM
Ignite Modification Date:
2025-12-24 @ 11:25 PM
NCT ID:
NCT05393856
Eligibility Criteria:
Key Inclusion Criteria:
1. Sex:Males and females
2. Age:18 to 55 years, inclusive, at screening
3. Weight:≥50 kg, at screening
4. Body mass index:18.0 to 30.0 kg/m2, inclusive, at screening
5. Smoking behavior :Non-smoking or smoking ≤5 cigarettes, 1 cigar, or 1 pipe per day
6. Other criteria:Liver enzymes within the normal range and creatine phosphokinase within 2.0 times the normal range
Key Exclusion Criteria:
1. Previous participation in the current study.
2. Employee of PRA or the Sponsor.
3. History of bacterial or viral infection requiring treatment with antibiotics or antivirals within 1 month prior to screening.
4. Presence or history of esophageal or gastroduodenal ulceration within 1 month prior to screening.
5. Significant and/or acute illness within 5 days prior to the first drug administration that may impact safety assessments, in the opinion of the Investigator.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT05393856
Study Brief:
Protocol Section:
NCT05393856