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

NCT06226805 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 228

Last updated 2026-05-14

No results posted yet for this study

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.

Conditions

  • Acute Ischemic Stroke

Interventions

DRUG

BB-031

Solution for injection

DRUG

Placebo

0.9% sodium chloride for injection

Sponsors & Collaborators

  • Basking Biosciences, Inc.

    lead INDUSTRY

Principal Investigators

  • Michael D Hill, MD · University of Calgary

  • Shahid M Nimjee, MD, PhD · Ohio State University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-31
Primary Completion
2027-06-30
Completion
2027-09-30
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06226805 on ClinicalTrials.gov