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 @ 5:37 PM
Ignite Modification Date:
2025-12-24 @ 5:37 PM
NCT ID:
NCT06067568
Eligibility Criteria:
Inclusion Criteria:
* Male and female healthy volunteers aged between 18 and 60 years.
\-- Part 2 only: Participant must be first-generation Han Chinese of full Chinese parentage residing outside of China. Participant must maintain a typical Chinese lifestyle, including consuming a typical Chinese diet.
* BMI \<= 18.0 to \<= 29.9 kg/m\^2 after rounding to the tenths decimal, at screening and upon initial confinement.
* A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile, and 12-lead electrocardiogram (ECG).
Exclusion Criteria:
* Use any medications, vitamins, and/or herbal supplements within the 2 week period or 5 half-lives (whichever is longer) prior to study drug administration.
* History of: epilepsy, any clinically significant cardiac, respiratory (except mild asthma), renal, hepatic ,gastrointestinal, hematologic, demyelinating disease (including myelitis) or neurologic symptoms suggestive of demyelinating disease, glaucoma, psychiatric disease or disorder, or any uncontrolled medical illness.
* Prior exposure to lutikizumab.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT06067568
Study Brief:
Protocol Section:
NCT06067568