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 @ 11:45 AM
Ignite Modification Date:
2025-12-24 @ 11:45 AM
NCT ID:
NCT05320861
Eligibility Criteria:
Inclusion Criteria:
* Body mass index (BMI) of 18.0 to 32.0 kg/m2 as measured at screening
* Must be willing and able to communicate and participate in the whole study
* Must have regular bowel movements
* Must provide written informed consent
* Must agree to adhere to the contraception requirements of the protocol
Exclusion Criteria:
* Subjects who have received any IMP in a clinical research study within the 90 days prior to Day 1
* Subjects who are, or are immediate family members of, a study site or sponsor employee
* Subjects who report to have previously received SJP-0008
* Evidence of current SARS-CoV-2 infection
* History of any drug or alcohol abuse in the past 2 years
* Regular alcohol consumption in males \>21 units per week
* A confirmed positive alcohol breath test at screening or admission
* Current smokers and those who have smoked within the last 6 months. A confirmed breath carbon monoxide reading of greater than 10 ppm at screening or admission
* Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 6 months
* Subjects with pregnant or lactating partners
* Radiation exposure, including that from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 2017, shall participate in the study
Other protocol-defined exclusion criteria may apply
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
50 Years
Maximum Age:
70 Years
Study:
NCT05320861
Study Brief:
Protocol Section:
NCT05320861