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 @ 3:55 PM
Ignite Modification Date:
2025-12-24 @ 3:55 PM
NCT ID:
NCT05107492
Eligibility Criteria:
Inclusion Criteria:
* Male and female participants must be 18 to 45 years of age, inclusive, at the time of signing the ICD.
* Male and female Chinese participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital sign and 12-lead ECG
* BMI of 19 to 27 kg/m2; and a total body weight \>50 kg.
Exclusion Criteria:
* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
* History of HIV infection, hepatitis B, hepatitis C or syphilis; positive testing for HIV, hepatitis B, HCVAb or serological reaction of syphilis.
* History of allergic or anaphylactic reaction to a therapeutic drug.
* History of recent active infections within 28 days prior to the screening visit.
* Participants with a fever within 48 hours prior to dosing.
* History of TB or active or latent or inadequately treated infection.
* Recent exposure to live vaccines within 28 days of the screening visit.
* A positive pregnancy test.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT05107492
Study Brief:
Protocol Section:
NCT05107492