임상시험 레이더

1. History of significant diseases, or any existing disease may affect the study or pose an unacceptable risk to the participant.
2. Positive for HBsAg, HIV-Ab, Treponema pallidum antibody, or HCV-Ab.
3. History of blood donation, significant blood loss (total volume ≥400 mL), or blood transfusion within 3 months prior to screening.
4. History of alcohol abuse within 1 year prior to screening; or positive alcohol breath test.
5. History of drug abuse and/or substance abuse; or positive drug screening.
6. Participation in any drug or medical device clinical trial within 3 months prior to screening.
7. Pregnant or lactating women, or women of childbearing potential with a positiveβ-hCG test.
8. Any other condition that, in the investigator's judgment, makes the participant unsuitable for participation in this study.

Exclusion Criteria for Part B:

1. Cognitive impairment or dementia caused by any disease other than AD.
2. History of stroke within 6 months prior to screening, or imaging evidence of clinically significant central nervous system diseases.
3. History of epileptic seizures or epileptiform abnormalities on EEG within 6 months prior to screening.
4. Unstable or severe diseases within 6 months prior to screening that, in the investigator's judgment, make the participant unsuitable for study participation.
5. eGFR <60 mL/min/1.73 m².
6. AST or ALT >3 × upper limit of normal (ULN), or total bilirubin >2 × ULN.
7. Current use or anticipated need during the study period for any medication prohibited by the study protocol.
8. Any other condition that, in the investigator's judgment, makes the participant unsuitable for participation in this study.