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 @ 12:09 PM
Ignite Modification Date:
2025-12-24 @ 12:09 PM
NCT ID:
NCT06789861
Eligibility Criteria:
Main inclusion criteria for Parts A and B:
* Non-smoker for the confinement period of the study.
* Medically healthy and without clinically significant abnormalities.
* Negative screen for alcohol and drugs of abuse.
* No history of psychiatric disorders.
* Female participants of non-childbearing potential must be post-menopausal or surgically sterile at least 3 months prior to dosing.
* Sexually active females of childbearing potential and non-sterile males must be willing to use an acceptable contraceptive method throughout the study.
* Able to understand the study procedures and provide signed informed consent to participate in the study in English.
Main exclusion criteria for Parts A and B:
* History of clinically significant asthma, anaphylaxis, major medical, psychiatric illness or surgery.
* Acute or chronic clinically relevant systemic disease or disorder.
* Renal insufficiency
* History of drug or alcohol consumption abuse.
* Drinking excessive amounts of tea, coffee, chocolate and/or beverage containing caffeine.
* Have used any investigational drug or participated in any clinical trial within 4 weeks prior to screening.
* Unable to refrain from strenuous exercise.
* Participant who has received blood or plasma derivatives, who had a surgery or who has given blood within 4 weeks prior to the screening visit or has planned to give blood or sperm within the 90 days following the study.
* Pregnant or lactating female participant.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT06789861
Study Brief:
Protocol Section:
NCT06789861