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 @ 5:54 PM
Ignite Modification Date:
2025-12-24 @ 5:54 PM
NCT ID:
NCT07029568
Eligibility Criteria:
Inclusion Criteria:
* Men, or women of non-childbearing potential.
* Age 18-55 years (both inclusive) at the time of signing the informed consent.
* Body mass index (BMI) between 18.5 to 29.9 kilogram per meter square (kg/m\^2) (both inclusive) at screening.
* Body weight: greater than or equal to (≥) 50 kilogram (kg) at screening.
* Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.
Exclusion Criteria:
* Known or suspected hypersensitivity to study intervention(s) or related products.
* Any condition, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
* Any of the below laboratory safety parameters at screening outside normal range, see designated reference range documents for specific values; Alanine Aminotransferase (ALT) greater than (\>) Upper limit of normal (ULN); Aspartate aminotransferase (AST) \> ULN; Total Bilirubin (BIL) \> ULN; Creatinine \> ULN; International normalized ratio (INR) \> ULN; High-Sensitivity C-Reactive Protein (hsCRP) \> 5 milligram per liter (mg/L) (males) and \> 8 mg/L (females)
* Use of prescription medicinal products or vaccines within 14 days before dosing and/or non-prescription medicinal products within 7 days before dosing. Exceptions are: Topical medications not reaching systemic circulation; less than once per week of over the counter paracetamol and/or acetylsalicylic acid at their labelled doses for mild pain; vitamins at their labelled doses.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT07029568
Study Brief:
Protocol Section:
NCT07029568