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:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-26 @ 3:19 PM
NCT ID:
NCT07314333
Eligibility Criteria:
Inclusion Criteria:
* Body mass index (BMI) between 18.0 to 32.0 kilogram per square meter (kg/m2).
* Must be in good health, based on:
* Medical history
* Physical examination
* Heart test (Electrocardiogram \[ECG\])
* Lab tests (blood, urine and other routine checks)
* Willing to stay in the clinic for the required time and agree to a follow-up phone call for safety.
* Able to sign informed consent and, in the investigator's opinion, follow all trial requirements.
Exclusion Criteria:
* History of drug and/or alcohol abuse in past 2 years.
* History of or current hepatitis or acquired immune deficiency syndrome (AIDS) or carriers of hepatitis B surface antigen (HBsAg) and/or anti-hepatitis C virus (HCV), or human immunodeficiency virus (HIV) antibodies.
* Known drug allergy or hypersensitivity.
* Any history of significant bleeding problems.
* Difficulty donating blood in the past.
* Use of tobacco or exposure to second-hand smoke in the past 2 months, or high cotinine levels in blood/urine.
* Uncontrolled high blood pressure (BP) (systolic blood pressure \[SBP\] \> 140 millimeters of mercury (mmHg) or diastolic blood pressure \[DBP\] \> 90 mmHg) or symptomatic low blood pressure, or orthostatic hypotension (large BP drop when standing).
* History of unexplained fainting (syncope).
* Serious mental health disorders that could interfere with participation.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT07314333
Study Brief:
Protocol Section:
NCT07314333