NCT06226805

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

A Multicenter, Double-blinded, Placebo-controlled, Single Ascending Dose, Two-part, Randomized, Phase 2 Clinical Trial to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BB-031 in Acute Ischemic Stroke Patients

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 228 (estimated)
• Sponsor: Basking Biosciences, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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 228 patients are planned in this study.

Detailed description

This is a two-part, randomized, placebo-controlled, double-blinded study in acute ischemic stroke patients. In Part A, up to 48 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 180 participants will be randomized to receive a single dose of two sequential 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 as outlined in the protocol.

Conditions

• Acute Ischemic Stroke

Interventions

Type	Name	Description
DRUG	BB-031	Solution for injection
DRUG	Placebo	0.9% sodium chloride for injection

Timeline

• Start date: 2024-07-31
• Primary completion: 2027-06-01
• Completion: 2027-09-01
• First posted: 2024-01-26
• Last updated: 2026-03-18

Locations

24 sites across 3 countries: United States, Australia, Canada

Regulatory

• FDA-regulated drug study