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 @ 5:06 PM
Ignite Modification Date:
2025-12-24 @ 5:06 PM
NCT ID:
NCT05178550
Eligibility Criteria:
Inclusion Criteria:
* Healthy subject
* Male or female
* 18 to 65 years, inclusive, at the time of signing informed consent
* Body mass index:18.0 kg/m \^2 to 29.9 kg/m\^2, inclusive, at the time of signing informed consent
* Body weight greater than or equal to 50 kg at the time of signing informed consent
Exclusion criteria:
* Using tobacco products within 60 days prior to the first drug administration.
* Any kind of coagulation disorder or any first degree family members with major bleeding tendency.
* History of anemia, thrombocytopenia, HIT, other blood disorders, or any clinically relevant bleeding (epistaxis).
* Exposure to heparin (unfractionated heparin or low molecular weight heparin) within 100 days prior to the first dose of heparin.
* Participation in any clinical study of an approved or non-approved investigational medicinal product within 30 days (or 5 half-lives of the investigational medicinal product, whichever is greater) before screening. If the half-life of the investigational medicinal product is unknown, subjects participating in a clinical trial in the 6 months prior to (the first) treatment administration will be excluded.
* Any kind of coagulation disorder or any first degree family members with major bleeding tendency.
* Unwillingness to consume the entire high-fat standardized meal (e.g. vegetarians, vegans and subjects who follow special diets).
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05178550
Study Brief:
Protocol Section:
NCT05178550