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

• Status: Not yet recruiting
• Trial end date: 2023-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: TrueBinding, Inc.

Criteria

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

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:

1. Acute ST elevation MI;

2. Acute decompensated heart failure, or New York Heart Association Class III/IV heart failure;

3. 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.

4. QT interval corrected using Bazett's formula (QTcB) >520 milliseconds (msec)