This multi-center, randomized, parallel-group, double-blind, placebo-controlled study will evaluate the efficacy and safety of TB006 in participants with an Acute Ischemic Stroke (AIS) event with 57 days of treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Percentage of Participants with Recovery Success Measured by modified Rankin Scale (mRS) score of 0-1 on the final mRS assessment.
The Modified Rankin Scale (mRS) measures neurological disability or dependence of participants with stroke on a scale of 0 to 6 and scores indicate the following: 0 - No symptoms; 1 - No significant disability; 2 - Slight disability; 3 - Moderate disability; 4 - Moderately severe disability; 5 - Severe disability; 6 - Dead. Higher score indicates worse condition.
Time frame: Day 90
Percentage of Participants with Clinically Significant Improvement on the National Institutes of Health Stroke Scale (NIHSS)
Clinically significant improvement is defined as a 4-point decrease on the NIHSS
Time frame: At Days 29, 57 and 85
Change from Baseline in Neurological Function on the NIHSS
The NIHSS is composed of 11 items, each of which rates a specific parameter of ability or function. Each item is rated on a scale of 0 to 4. A score of 0 indicates normal function, with higher scores indicating greater degree of impairment. The individual item scores are added to calculate the NIHSS total score. The minimum score being a 0 (no impairment) and maximum possible score is 42 (death). Higher scores indicate worse condition.
Time frame: Baseline and through Day 85
Percentage of Participants with Clinically Significant Improvement on the mRS
Clinically Significant Improvement is defined as 1-point decrease on the mRS
Time frame: At Days 29, 57 and 85
Change from Baseline in the Montreal Cognitive Assessment (MoCA) Total Score
The MoCA is a brief screening instrument designed to assess mild cognitive impairment in a variety of participant conditions. The MoCA assesses eight cognitive domains: visuospatial ability, executive function, short-term memory recall, attention, concentration, working memory, language, and orientation to time and space. Scores on the MoCA range from 0 to 30, with lower scores indicating greater impairment.
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Time frame: Baseline and at Days 29, 57, and 85
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Up to Day 141
Number of Participants with Clinically Significant Clinical Laboratory Parameter Values
Time frame: Up to Day 141
Number of Participants with Clinically Significant Vital Sign Values
Time frame: Up to Day 141
Number of Participants with Clinically Significant 12-Lead Electrocardiogram Findings
Time frame: Up to Day 141
Number of participants with Columbia Suicide Severity Rating Scale (C-SSRS) Score
The C-SSRS is a suicidal ideation and behavior rating scale with yes/no responses. For each of the 5 items of the C-SSRS related to suicidal ideation intensity, an individual's degree of suicidal ideation is rated on a 0-5 scale with 0: no suicidal behavior and 5: active suicidal ideation. The total score is the sum of the 5 intensity item scores (total score ranges from 0 to 25). Higher scores in the scale indicate greater disease severity.
Time frame: Up to Day 141
Number of Participants with Clinically Significant Physical Examination Findings
Time frame: Up to Day 141
Number of Participants with Anti-drug Antibodies
Time frame: Up to Day 141
Plasma concentration of TB006
Time frame: Pre-dose and post-dose on Days 1, 29, 57, 85 and 141