A Study to Assess the Efficacy, Safety, and Pharmacokinetics of TB006 in Participants With Acute Ischemic Stroke

Sponsor

TrueBinding, Inc. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05156827

Collaborator

(none)

120

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

This study will be conducted to determine the clinical efficacy of TB006 in participants with acute ischemic stroke.

Condition or Disease	Intervention/Treatment	Phase
Acute Ischemic Stroke	Drug: TB006 Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Phase 2 Double-blind, Randomized, Multi-center, Parallel-group Study to Assess the Efficacy, Safety, and Pharmacokinetics of TB006 in Patients With Acute Ischemic Stroke

Anticipated Study Start Date :

Apr 1, 2022

Anticipated Primary Completion Date :

Apr 1, 2023

Anticipated Study Completion Date :

Apr 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TB006 Participants will receive an intravenous (IV) infusion of TB006 1000 milligrams (mg) once weekly for 5 weeks.	Drug: TB006 TB006 diluted in normal saline, administered through IV infusion over an hour
Placebo Comparator: Placebo Participants will receive an IV infusion of normal saline once weekly for 5 weeks.	Drug: Placebo Normal saline administered through IV infusion over an hour

Arm

Intervention/Treatment

Experimental: TB006

Participants will receive an intravenous (IV) infusion of TB006 1000 milligrams (mg) once weekly for 5 weeks.

Drug: TB006

TB006 diluted in normal saline, administered through IV infusion over an hour

Placebo Comparator: Placebo

Participants will receive an IV infusion of normal saline once weekly for 5 weeks.

Drug: Placebo

Normal saline administered through IV infusion over an hour

Outcome Measures

Primary Outcome Measures

Number of Participants with Recovery Success Measured by modified Rankin Scale (mRS) score of 0-1 on the final mRS assessment. [Day 90]
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.

Secondary Outcome Measures

Number of Participants with Clinically Significant Improvement on the National Institutes of Health Stroke Scale (NIHSS) [Day 36 through Day 90]
Clinically significant improvement is defined as a 4-point decrease on the NIHSS
Change from Baseline in Neurological Function on the NIHSS [Day 36 and Day 90]
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).
Number of Participants with Clinically Significant Improvement on the Modified Rankin Scale (mRS) [Day 36 through Day 90]
Clinically Significant Improvement is defined as 1-point decrease on the mRS
Change from Baseline in the Fugl-Meyer Assessment (FMA) Total Score [Baseline; Day 36 and Day 90]
Change from Baseline in the Montreal Cognitive Assessment (MoCA) Total Score [Baseline; Day 36 and Day 90]
Number of Participants with Treatment-Emergent Adverse Events and Treatment-Emergent Serious Adverse Events [up to Day 90]
Number of Participants with Clinically Significant Clinical Laboratory Parameter Values [up to Day 90]
Number of Participants with Clinically Significant Vital Sign Values [up to Day 90]
Number of Participants with Clinically Significant 12-Lead Electrocardiogram Findings [up to Day 90]
Change from Baseline in the Columbia Suicide Severity Rating Scale (C-SSRS) Score [Baseline; Day 90]
The Columbia-Suicide Severity Rating Scale (C-SSRS) is a semi-structured clinical interview that assesses suicidal ideation severity, suicidal ideation intensity, and suicidal behavior. Higher scores in the scale indicate greater disease severity
Number of Participants with Clinically Significant Physical Examination Findings [up to Day 90]
Number of Participants with Anti-drug Antibodies [up to Day 90]
Mean Area Under the Concentration Time Curve over a Dosing Interval (AUC0-tau) at Steady State [Pre-dose and post-dose on Days 1, 8 and 29; post-dose on Days 36, 64 and 90]
Mean Maximum Observed Plasma Concentration (Cmax) [Pre-dose and post-dose on Days 1, 8 and 29; post-dose on Days 36, 64 and 90]
Mean Concentration at the End of a Dosing Interval (Ctrough) [Pre-dose and post-dose on Days 1, 8 and 29; post-dose on Days 36, 64 and 90]
Median Terminal Elimination Phase Half-life (t1/2) [Pre-dose and post-dose on Days 1, 8 and 29; post-dose on Days 36, 64 and 90]
Median Time to Cmax (tmax) [Pre-dose and post-dose on Days 1, 8 and 29; post-dose on Days 36, 64 and 90]
Mean Clearance (CLss) at Steady State [Pre-dose and post-dose on Days 1, 8 and 29; post-dose on Days 36, 64 and 90]
Mean Volume at Steady State (Vss) [Pre-dose and post-dose on Days 1, 8 and 29; post-dose on Days 36, 64 and 90]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Body Mass Index (BMI) between 18 and 40 kilograms per meters squared (kg/m^2), inclusive
Clinical diagnosis of acute ischemic stroke (AIS) in anterior circulation, supported by acute brain computed tomography (CT) scan or magnetic resonance imaging (MRI) consistent with the clinical diagnosis.
Able to be randomized and dosed within 7 days of index stroke event. The last known awake time will be used for participants whose stoke occurred during sleep.
National Institute of Health Stroke Scale total score of 7 to 21, inclusive
Participants who have received recombinant tissue plasminogen activator (r-tPA) within the first day of their stroke event are eligible. However, study drug administration must begin more than 24 hours following r-tPA administration.

Exclusion Criteria:

Evidence of severe stroke on imaging (e.g., sulcal effacement or blurring of gray-white junction in greater than 1/3 of middle cerebral artery [MCA] territory, Alberta Stroke Program Early CT [ASPECT] score of 0 to 4 based on head CT, acute infarct volume on MRI diffusion weighed imaging ≥70 milliliters (mL) based on acute imaging studies performed under the standard of care
Lacunar or isolated brainstem or cerebellar stroke based on clinical assessment and available acute imaging studies performed under the standard of care
Evidence of seizure at the onset of index stroke
Evidence of acute myocardial infarction (MI) at Baseline, including any of the following:

Acute ST elevation MI;
Acute decompensated heart failure, or New York Heart Association Class III/IV heart failure;
Admission for an acute coronary syndrome, MI, cardiac arrest, or non-voluntary coronary intervention (percutaneous coronary intervention or coronary artery surgery) within the past 3 months.
QT interval corrected using Bazett's formula (QTcB) >520 milliseconds (msec)