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:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2025-12-25 @ 4:03 AM
NCT ID:
NCT06097702
Eligibility Criteria:
Inclusion Criteria:
* 18 to 50 years of age
* In good general health at Screening and/or before the first administration of IP
* BMI \> 18.0 and \< 32.0 kg/m2 at Screening
* Nonsmoker and must not have used any tobacco products within 2 months prior to screening
* Females must not be pregnant or lactating, and females and males must use acceptable, highly effective double contraception during study and follow-up period
* Person who can provide written informed consent prior to the commencement of all study procedures
Exclusion Criteria:
* Underlying physical or psychological medical condition to comply with the protocol or complete the study per protocol
* Genetic disorder with severe and abnormal bilirubin metabolism
* Blood or plasma donation or significant blood loss prior to the first administration of IP
* Viral or bacterial infection prior to the first administration of IP
* Poor venous access
* Significant scarring or tattoos at the planned site of IP administration
* History of severe allergic or anaphylactic reactions, or sensitivity to the IP or its constituents
* History or active cardiovascular, respiratory, kidney, endocrine, blood, digestive, central nervous, urinary and/or musculoskeletal disease
* History of malignancy prior to Screening
* Abnormal ECG findings
* History or presence of a condition associated with significant immunosuppression
* History of life-threatening infection
* Infections requiring parenteral antibiotics
* Vaccination prior to the first administration of IP
* Exposure to any significantly immune suppressing drug
* Abnormal vital signs findings
* Abnormal laboratory findings
* Positive results for viral testing at Screening
* Positive result at Screening and Day -1 for toxicology screening panel
* History of substance abuse or dependency or history of recreational intravenous (IV) drug use
* Excess of regular alcohol consumption
* Use of any IP or investigational medical device within 30 days prior to Screening
* Unable to adhere to the prohibited therapies
* Unwilling to adhere to the dietary restrictions
* Unwilling to refrain from strenuous exercise
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT06097702
Study Brief:
Protocol Section:
NCT06097702