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

NCT ID: NCT05156827

Last Updated: 2024-01-12

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-26
• Study Completion Date: 2023-12-18

Brief Summary

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.

Conditions

Acute Ischemic Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

TB006

Participants will receive intravenous (IV) 3 infusions of 4000 milligrams (mg) TB006, one every 28 days (Q28D).

Group Type: EXPERIMENTAL

TB006

Intervention Type: DRUG

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

Placebo

Participants will receive an IV infusion of normal saline 500 milliliters (mL) Q28D.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Normal saline administered through IV infusion over an hour

Interventions

TB006

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

Intervention Type: DRUG

Placebo

Normal saline administered through IV infusion over an hour

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Body Mass Index (BMI) between 18 and 40 kilograms per meters squared (kg/m^2), inclusive
• Clinical diagnosis of AIS in anterior circulation, supported by evidence of a new stroke on acute brain computed tomography (CT) 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 may have received standard of care therapy including recombinant tissue plasminogen activator (r-tPA), thrombectomy, mannitol, hypertonic saline, and other treatments per local guidelines as determined by the Investigator. Participants who have received 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 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).

• Evidence of acute intracranial or subarachnoid hemorrhage or evidence of active bleeding based on acute brain CT or MRI performed under the standard of care. However, petechial hemorrhages of ≤ 1 centimeter (cm) are not exclusionary.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

TrueBinding, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

TrueBinding, Inc.

Role: STUDY_DIRECTOR

TrueBinding, Inc.

Other Identifiers

TB006AIS2103

Identifier Type: -

Identifier Source: org_study_id