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 @ 4:01 AM
Ignite Modification Date:
2025-12-25 @ 4:01 AM
NCT ID:
NCT06005402
Eligibility Criteria:
Major Inclusion Criteria:
* Healthy male or female subjects, aged 18 to 50 years, inclusive,
* Minimum weight of 50.0 kg and maximum weight of 100.0 kg
* Body mass index (BMI) within the range of 18.0 to 32.0 kg/m2, inclusive
Major Exclusion Criteria:
* Positive UDS for substances of abuse (including alcohol) at Screening or admission to the Treatment Phase
* Current daily cigarette smoker within 3 months of Screening. Social smoking, as defined by non-daily use of nicotine-containing products, is permitted.
* History or presence of any clinically significant cardiac, psychiatric, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, renal, or other major disease or illness at Screening, which in the opinion of the Investigator, might jeopardize the safety of the subject or the validity of the study results.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT06005402
Study Brief:
Protocol Section:
NCT06005402