A Safety and Tolerability Study of GB301 Given as a Single Intravenous Dose in Subjects With Mild to Moderate Alzheimer's Disease

Number of subjects with abnormal clinical chemistry parameters

时间窗: Between Baseline and 12 weeks

Blood samples will be collected for the assessment of following clinical chemistry parameters: Albumin, Total bilirubin, Total protein, Calcium, alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), blood urea nitrogen (BUN), Creatinine, Glucose, Sodium, Potassium, Chloride, Bicarbonate, LDH, FSH, Uricacid

Columbia Suicide Severity Rating Scale (C-SSRS)

时间窗: Between Baseline and 12 weeks

The C-SSRS captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. Some questions are yes/no and some are on a scale of 1 (low severity) to 5 (high severity). Completed suicide and non-fatal suicide events are yes/no questions and results presented are the number of participants with these events.

Number of subjects With Clinically Significant Abnormalities in 12-lead Electrocardiogram

时间窗: Between Baseline and 12 weeks

The number of subjects with normal and abnormal ECG findings will be summarized for each treatment group at each time point. Clinical significance was determined by the investigator. ECG measures PR interval (ms), QRS interval, QT interval(ms), QTc interval (ms), and heart rate(bpm) for each treatment group at each time point.

Number of subjects with abnormal Coagulation parameters

时间窗: Between Baseline and 12 weeks

Blood samples will be collected for the assessment of following coagulation parameters: Prothrombin Time(PT), International normalized ratio(INR), partial thromboplastin time (PTT)

Number of subjects with adverse events (AEs)

时间窗: Between Baseline and 12 weeks

An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.

Number of subjects with abnormal Hematology parameters

时间窗: Between Baseline and 12 weeks

Blood samples will be collected for the assessment of following hematology parameters: red blood cell (RBC) count, Hemoglobin, Hematocrit, mean corpuscular volume (MCV),mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), Platelet, white blood cell (WBC) count, Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil

Number of subjects with abnormal Urinalysis parameters

时间窗: Between Baseline and 12 weeks

Samples will be collected to measure specific gravity, potential of hydrogen (pH), glucose, protein, blood and ketones.

Number of subjects with abnormal physical examination

时间窗: Between Baseline and 12 weeks

A full physical examination will include assessments of the general apperance, skin, head, neck, eyes, ears, nose, throat, respiratory, cardiovascular, abdomen, extremities, musculoskeletal, neurological, lymph nodes etc.

Number of subjects with abnormal vital signs

时间窗: Between Baseline and 12 weeks

Vital signs, including height (only assessed at Screening), weight, systolic and diastolic blood pressure, heart rate, and body temperature, will be measured after the subject has been in a sitting position for 5 minutes.