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 @ 4:07 AM
Ignite Modification Date:
2025-12-25 @ 4:07 AM
NCT ID:
NCT05005520
Eligibility Criteria:
Inclusion Criteria:
* 18-55 years of age
* Ability to provide written consent
* Weight 50-110 kg with BMI 18.5-32 kg/m2
* Willingness to use contraceptives
* Negative COVID-19 test
* Negative results for alcohol and drugs of abuse
Exclusion Criteria:
* Pregnant or lactating females
* Familial bleeding disorder or individual or family history of bleeding diathesis or coagulopathy
* Females with active menstruation on day of dosing
* Use of prescription medications known to affect platelet function
* Use of NSAIDs, aspirin, anti-platelet or anti-coagulation therapy within 10 days of dosing
* Contraindication to anticoagulation or increased bleeding risks
* History of thrombocytosis, high platelet count, intracranial bleeding, aneurysm, stroke, vascular disease
* History of peptic ulcer disease, gastrointestinal or genitourinary bleed, severe trauma, fracture, major surgery of biopsy of parenchymal organ within past 3 months
* Planned surgery during the study
* Any clinical significant abnormality at screening
* Use of investigational drug in past 30 days or 5 half lives
* Concurrent enrollment in another clinical study or more than 3 clinical studies in past 12 months
* Any prior history of substance abuse or treatment or positive urine screen for drugs of abuse or positive breathalyzer test
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT05005520
Study Brief:
Protocol Section:
NCT05005520