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 @ 6:25 PM
Ignite Modification Date:
2025-12-24 @ 6:25 PM
NCT ID:
NCT07245368
Eligibility Criteria:
Phase 1
Inclusion Criteria:
* Age 18-65
* Must be in good health with no significant medical history
* Willing and able to attend all study visits, comply with study requirements
* Able and willing to provide written informed consent
Exclusion Criteria:
* Evidence of clinically significant condition or disease
* Any physical or psychological condition that prohibits study completion
* Known history of illicit drug use or drug abuse, harmful alcohol use (at the Investigator's discretion), alcoholism, and/or smoking or nicotine-containing product use within 3 months prior to the first dose of study agent
* History of severe allergic reactions or hypersensitivity
* Donation or loss of ≥ 1 unit of whole blood or plasma within 2 months prior to dosing
Phase 2a
Inclusion criteria:
* Age 18-65
* Must be in good health with no significant medical history
* Willing and able to attend all study visits, comply with study requirements.
* Able and willing to provide written informed consent
* Documented asthma diagnosis prior for at least 12 months prior to screening.
* Symptomatic asthma
* Currently receiving maintenance asthma medications
Exclusion Criteria:
* Evidence of clinically significant condition or disease
* Known history of illicit drug use or drug abuse, harmful alcohol use (at the Investigator's discretion), alcoholism, and/or smoking or nicotine-containing product use within 3 months prior to the first dose of study agent
* Donation or loss of ≥ 1 unit of whole blood or plasma within 2 months prior to dosing
* History of severe allergic reactions or hypersensitivity
* Current or former smoker with a smoking history of ≥10 pack-years
* Receipt of immunosuppressant therapies or biologic therapy for asthma within 6 months of screening
* Other investigational agent(s) within 30 days of dosing
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT07245368
Study Brief:
Protocol Section:
NCT07245368