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:
2025-12-26 @ 10:17 PM
Ignite Modification Date:
2025-12-26 @ 10:17 PM
NCT ID:
NCT04994912
Eligibility Criteria:
Inclusion Criteria:
1. Healthy male or female 18 to ≤ 55 years old at the time of consent.
2. Healthy on the basis of physical examination, medical history, vital signs, laboratory values and 12-lead ECG performed at Screening. The participant may be included only if the investigator judges any abnormalities or deviations from normal to be not clinically significant.
Exclusion Criteria:
1. Prior or ongoing medical conditions, medical history, physical findings, or laboratory abnormality that, in the Investigator's (or delegate's) opinion, may require treatment or render the participant unlikely to fully complete the study, or any condition that presents undue risk from the IP or procedures or interfere with study assessments.
2. Have received any IP within 30 days or 5 half-lives prior to Screening (4 months if the previous drug was a new chemical entity), whichever is longer.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT04994912
Study Brief:
Protocol Section:
NCT04994912