A Clinical Trial of AK152 in Healthy Volunteers and Patients With Alzheimer' s Disease

Exclusion Criteria

• •1. Known allergy to components of AK152 injection or any monoclonal antibody, or high risk of allergy.
• •2. History or presence of any systemic disease that may interfere with study results.
• •3. Clinically significant abnormalities in vital signs at screening or prior to randomization.
• •4. Clinically significant laboratory abnormalities at screening or prior to randomization per investigator judgment.
• •5. Use of any medication (including prescription, OTC, herbal medicines, dietary supplements) within 4 weeks before randomization or within 5 half-lives of the medication (whichever is longer), or planned use during the study.
• •6. History of frequent alcohol consumption within 24 weeks or inability to abstain during inpatient stay.
• •7. Drug abuse or positive urine drug screen at screening.
• •8. Smokers consuming \>5 cigarettes/day within 12 weeks prior to screening or unable to abstain during the inpatient period.
• •9. Excessive intake of tea, coffee, or other caffeine-containing beverages.
• •1. History or evidence of malignancy involving any organ system within 5 years prior to screening, regardless of treatment or remission status (except completely cured carcinoma in situ of the cervix, non-metastatic squamous cell carcinoma of the skin, or basal cell carcinoma).
• •2. Severe or unstable disease at screening or prior to randomization that may affect study assessments.
• •3. Major neurological disorder (other than AD) that may affect cognition or ability to complete study procedures.
• •4. Transient ischemic attack (TIA) or stroke within 12 months prior to randomization.
• •5. Clinically significant abnormalities on brain MRI at screening.
• •6. Known allergy to components of AK152 injection or any monoclonal antibody, or high risk of allergy.
• •7. History of alcohol or drug abuse within 2 years prior to screening or prior to randomization.