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 @ 1:27 AM
Ignite Modification Date:
2025-12-25 @ 1:27 AM
NCT ID:
NCT07042594
Eligibility Criteria:
Main Inclusion Criteria:
* Male or female healthy participants (non-childbearing potential only), aged 18 to 65 years at screening, inclusive.
* Body mass index (BMI) between 18 and 32 kg/m2, inclusive
* APTT, Prothrombin time (PT), INR, thrombin time (TT) within normal reference range (as per the local laboratory).
* Haematology results within normal range, unless deemed not clinically significant by the Principal Investigator or delegate. Platelet count however must be within normal range per the local laboratory reference ranges.
* Healthy as determined by no clinically significant findings by the Principal Investigator or delegate in medical history, vital signs, physical examination, clinical laboratory assessments, and 12-lead electrocardiogram (ECG).
Main Exclusion Criteria:
* Any uncontrolled or serious disease that may interfere with participation in the clinical trial and/or put the participant at significant risk (according to Principal Investigator or delegate's judgment) if he/she participates in the clinical trial.
* History or presence of cardiovascular disease (including peripheral artery and cerebrovascular disease).
* Systolic blood pressure (SBP) is less than 90 or greater than 140 mmHg and/or diastolic blood pressure (DBP) is less than 50 or greater than 95 mmHg after 10 minutes of supine rest, unless determined by the Principal Investigator or delegate to be not clinically significant.
* Diagnosis of diabetes mellitus, history of gestational diabetes that has not been fully resolved is not permitted.
* History or presence of:
* Bleeding disorder(s) and/or at risk of bleeding, including relevant familial history, such as Hemophilia A, Hemophilia B, Wiskott-Aldrich syndrome, von Willebrand disease (vWD);
* Clinically significant anemia, in the opinion of the Principal Investigator or delegate;
* Thromboembolic diseases;
* Bleeding in the gastrointestinal tract or central nervous system;
* Anticipated need for oral surgery or tooth extractions during the trial period;
* Bleeding in the genitourinary tract;
* Gum disease or active gum bleeding;
* Planned surgery during the trial period.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT07042594
Study Brief:
Protocol Section:
NCT07042594