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 @ 3:26 AM
Ignite Modification Date:
2025-12-25 @ 3:26 AM
NCT ID:
NCT06336005
Eligibility Criteria:
Inclusion Criteria:
1. Men or women of non-childbearing potential.
2. Age 18-55 years (both inclusive) at the time of signing the informed consent.
3. Body mass index (BMI) between 18.5 to 29.9 kg/m\^2 (both inclusive) at screening.
4. Body Weight: Greater than or equal to 50 kg at screening.
5. 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:
1. Known or suspected hypersensitivity to study intervention(s) or similar products.
2. Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
3. Any of the below laboratory safety parameters at screening outside normal range, see designated reference range documents for specific values:.
* Alanine Aminotransferase (ALT) above upper normal limit (UNL)
* Aspartate aminotransferase (AST) above UNL
* Total Bilirubin (BL) above UNL
* Creatinine above UNL
* International normalized ratio (INR) above UNL
* Fibrinogen outside normal range of 1.6 - 4.2 gram pr. Liter (g/L)
* C-reactive protein (CRP) above 5 milligram pr. Liter (mg/L) (males) and above 8 mg/L (females)
4. 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, ibuprofen 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:
NCT06336005
Study Brief:
Protocol Section:
NCT06336005