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 @ 12:58 AM
Ignite Modification Date:
2025-12-25 @ 12:58 AM
NCT ID:
NCT03170193
Eligibility Criteria:
Inclusion Criteria:
1. Healthy men and women ≥ 18 to ≤ 55 years old with no history or evidence of clinically relevant medical disorders
2. Body mass index (BMI) between 18 and 32 kg/m², inclusive, at screening
3. Women must be of non-reproductive potential as defined in protocol
4. Other inclusion criteria may apply
Exclusion Criteria:
1. Currently receiving treatment in another investigational device or drug study, or less than 30 days or 5 half-lives (whichever is longer), since ending treatment on another investigational device or drug study(s) prior to receiving the first dose of investigational product
2. Women who are lactating/breastfeeding or who plan to breastfeed while on study through 90 days after receiving the dose of investigational product
3. Men with partners who are pregnant or planning to become pregnant while the subject is on study through 90 days after receiving the dose of investigational product
4. Positive pregnancy test at screening or day -1
5. Other exclusion criteria may apply
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT03170193
Study Brief:
Protocol Section:
NCT03170193