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 @ 12:47 PM
Ignite Modification Date:
2025-12-24 @ 12:47 PM
NCT ID:
NCT06650761
Eligibility Criteria:
Key Inclusion Criteria:
* An informed consent signed and dated by the participant.
* Healthy volunteer aged 18-55.
* In generally good health and without significant medical conditions based on physical exam, ECG, and laboratory test results.
* Body mass index (BMI) ≥ 18 kg/m2 to ≤ 32 kg/m2.
* No course of medication, whether prescribed or over the counter, in the 4 weeks before study drug administration.
* Both males and females of childbearing potential must agree to use a medically accepted contraceptive regimen during study and up to 150 days afterwards.
* Not a current smoker (or regular user of any nicotine containing product).
* Willing to follow all study rules.
Key Exclusion Criteria:
* Women who are pregnant or nursing.
* History of anaphylaxis, food allergies, or allergies (chronic or seasonal) requiring prescription medication.
* History of asthma requiring the use of inhaled medication within the past 5 years.
* Vaccination within 4 weeks prior to study drug administration (subjects must agree to avoid vaccination during the study).
* Blood donation (excluding plasma donation) of approximately 500 mL within 56 days prior to Screening.
* Positive urine test for alcohol and drugs of abuse.
Additional protocol defined inclusion and exclusion criteria could apply.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT06650761
Study Brief:
Protocol Section:
NCT06650761