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 @ 4:52 PM
Ignite Modification Date:
2025-12-24 @ 4:52 PM
NCT ID:
NCT06670950
Eligibility Criteria:
Inclusion Criteria:
* Males or females of non-childbearing potential (WOCBP) aged 18 to 65 years old (inclusive) at the date of signing the informed consent form (ICF).
* Normal ECG, showing no clinically relevant deviations, as judged by the investigator.
* Body mass index (BMI) between 18 and 30 kg/m2, inclusive, at Screening and Admission (e.g Day -1 or Day -2) and a minimum weight of 50kg.
Exclusion Criteria:
* Current or recurrent disease that as judged by the Investigator may interfere with the execution of the conduct of the study.
* Laboratory parameters outside of the laboratory normal range.
* Positive test results for alcohol or drugs of abuse.
* Treatment with an investigational drug within 90 days preceding the first dose of trial medication.
* Known or suspected intolerance or hypersensitivity to the investigational product, any closely related compound, or any of the stated ingredients.
* History of significant allergic reactions (anaphylaxis, angioedema) to any product (food, pharmaceutical, etc).
* Current smokers and those who have smoked within the last 6 months.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT06670950
Study Brief:
Protocol Section:
NCT06670950