A Safety and Tolerability Study of GB301 Given as a Single Intravenous Dose in Subjects With Mild to Moderate Alzheimer's Disease
Trial Snapshot
- Phase
- Phase 1
- Sponsor
- VTBIO Co. LTD
- Enrollment
- 20
- Locations
- 2
- Primary Endpoint
- Number of subjects with abnormal clinical chemistry parameters
Study Overview
Brief Summary
The primary objective of this study is to evaluate the safety and tolerability of multiple intravenous (IV) infusions at a single dose strength of GB301 in subjects with mild to moderate AD.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 40 Years to 72 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Regulatory T cells
Biologicals: Autologous Regulatory T cells (1.7*10^5 cells/kg, i.v) other name: GB301
Intervention: Regulatory T cells (Biological)
Placebo
Saline+cell suspension solution infusion
Intervention: Saline (Other)
Outcomes
Primary Outcomes
Number of subjects with abnormal clinical chemistry parameters
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
- Change from baseline in MMSE score(baseline, 29, 57, and 85 days)
- Change from Baseline in Alzheimer´s Disease Assessment Scale- Cognitive Subscale (ADAS-Cog-13) Score(baseline, 29, 57, and 85 days)