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 @ 7:16 PM
Ignite Modification Date:
2025-12-24 @ 7:16 PM
NCT ID:
NCT07285603
Eligibility Criteria:
Inclusion Criteria:
* Provision of written informed consent
* Male or female, aged 18 - 55 years at time of informed consent
* BMI between 18.0 - 30.0 kg/m2
* Normal vital signs (resting pulse rate and resting blood pressure)
* Normal ECG parameters (PR, QRS, QTc)
* Normal coagulation parameters (aPTT, PTT/INR and thrombin time)
* Female subjects must have a negative serum pregnancy test
* Willing and able to adhere to contraceptive requirements
Exclusion Criteria:
* History of clinically significant medical illness
* Laboratory abnormalities
* Major surgery or trauma in previous 6 months
* Positive test for HIV, HBsAg, or HCV
* History of heart arrhythmias, tachycardia at rest, or history of risk factors for Torsade de Pointes syndrome
* Clinically relevant allergy or drug hypersensitivity (incl. heparin)
* Smokes daily more than 5 cigarettes or equivalent
* History of postural disorders
* Lack of adequate venous access
* Current or ongoing history of urinary retention
* Use of prescription or nonprescription medication within 7 days prior to Day 1
* Received an investigational drug or medical device recently, or \>3 investigational agents in last 12 months, or currently enrolled in an investigational study
* Donated blood or substantial blood loss within 60 days prior to Day 1
* Any condition, preplanned surgery or procedure that would interfere with the study conduct and/or with the subject's best interest
* Subject is vulnerable
* Subject is an employee of the investigator, clinical site, or Sponsor
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT07285603
Study Brief:
Protocol Section:
NCT07285603