Study of BB-031 in Acute Ischemic Stroke Patients (RAISE)

Basking Biosciences

Status and phase: Enrolling; Phase 2

Conditions: Acute Ischemic Stroke

Treatments: Drug: Placebo; Drug: BB-031

Study type: Interventional

Funder types: Industry

Identifiers

NCT06226805

BB-031-CLIN-201

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and tolerability of ascending doses (Part A) and selected doses (Part B) of BB-031 in acute ischemic stroke patients presenting within 24 hours of stroke onset.

Participants will be randomized to receive one dose of either the investigational drug or placebo and will be followed for 90 days. A total of 156 patients are planned in this study.

Full description

This is a two-part, randomized, placebo-controlled, double-blinded study in acute ischemic stroke patients. In Part A, approximately 36 participants will be randomized in a 3:1 ratio (investigational drug: placebo) into 1 of 3 planned ascending dose groups to determine the dose levels to be studied in Part B. Two dose levels will be chosen based upon a review of all available data including safety, PK, PD and preliminary efficacy. In Part B, approximately 120 participants will be randomized in a 1:1:1 ratio to receive a single dose of two dose levels of study drug or placebo.

All participants will be screened for participation after confirmed diagnosis of an anterior circulation ischemic stroke by neurovascular imaging. Enrolled participants will be followed for 90 days. Radiological outcomes will be assessed by a central blinded reviewer. A Data Safety Monitoring Committee will review safety and preliminary efficacy data throughout the study.

Enrollment: 156 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of acute ischemic stroke
• 18 years or older
• Anterior circulation intra-cranial occlusion
• Onset of stroke symptoms within 24 hours of enrollment

Exclusion criteria

• Large volume ischemic stroke
• Intracranial hemorrhage on baseline imaging or previous intracranial hemorrhage
• Chronic intracranial occlusion
• Weight >125kg
• Administration of thrombolytic drug or glycoprotein IIb/IIIa inhibitors
• Ongoing clinically significant coagulopathy, history of bleeding disorder or other conditions for high-risk bleeding or active uncontrolled bleeding
• Prior stroke within 90 days
• Unable to undergo a contrast brain perfusion scan with either MRI or CT

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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156 participants in 2 patient groups, including a placebo group

BB-031

Experimental group

Description:

A single dose of BB-031 will be administered via IV bolus injection

Treatment:

Drug: BB-031

Placebo

Placebo Comparator group

Description:

A single dose of matching placebo will be administered via IV bolus injection

Treatment:

Drug: Placebo