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 @ 6:51 PM
Ignite Modification Date:
2025-12-24 @ 6:51 PM
NCT ID:
NCT05328557
Eligibility Criteria:
For healthy subject cohorts,
Inclusion Criteria:
* Non-smoking adult healthy male and female, aged 18 to 65 years (inclusive), at the time of consent with a body mass index (BMI) between 18.0 and 32.0 kg/m2 (inclusive), at Screening.
* Healthy as determined by medical history, physical examination, vital signs, clinical laboratory safety tests, ECG, and chest X-ray
Exclusion Criteria:
* Active bacterial, viral, fungal infection or known inflammatory process, infection or antibiotic treatment
* Laboratory test results outside the local reference range and deemed clinically significant
* History of chronic medications, immunosuppressant or steroids
* History of malignant neoplasm
* History of relevant atopy
* History of hypersensitivity to biologic agents or any of the excipients in the formulation.
* Excessive xanthine consumption
* History of drug or alcohol addiction or dependence within 1 year
* Positive of a tuberculosis test or a history of tuberculosis
* Abnormal blood pressure and/or ECG parameters
* Any prescribed medications within 28 days or nonprescription drugs within 7 days
* Previously received aldesleukin or any other IL-2 derivative
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05328557
Study Brief:
Protocol Section:
NCT05328557