BB-031 for Stroke

(RAISE Trial)

Recruiting at 15 trial locations

Overseen By Program Director

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Basking Biosciences, Inc.

Must not be taking: Thrombolytics, Glycoprotein IIb/IIIa inhibitors

Disqualifiers: Large stroke, Hemorrhage, Coagulopathy, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1 day

156 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to test the safety and tolerability of a new drug, BB-031, for individuals who have experienced an acute ischemic stroke. Participants will receive either the drug or a placebo (a harmless pill with no effect) to monitor their response over 90 days. The trial seeks individuals who have had a stroke within the last 24 hours, with a blockage in the brain's blood vessels. Those whose stroke recently affected their ability to move or speak may be suitable candidates. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering a chance to contribute to important medical advancements.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are taking thrombolytic drugs or glycoprotein IIb/IIIa inhibitors, you may not be eligible to participate.

Is there any evidence suggesting that BB-031 is likely to be safe for humans?

Research has shown that BB-031 is safe and well-tolerated in past studies. In one study, participants took single doses up to 4.0 mg/kg without serious side effects. This indicates that the drug did not cause major health issues. Another study found BB-031 safe over 28 days, with no new side effects emerging during that period. These findings suggest that BB-031 is generally well-tolerated in humans. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for stroke?

Unlike standard stroke treatments, which often focus on dissolving clots or reducing blood pressure, BB-031 is unique because it is administered via a single IV bolus injection, potentially offering rapid intervention. This new approach may allow for quicker treatment of stroke symptoms, which is crucial for minimizing long-term damage. Researchers are excited about BB-031 because it promises a novel mechanism of action that could work faster than existing options, providing stroke patients with timely and effective care.

What evidence suggests that BB-031 might be an effective treatment for stroke?

Research shows that BB-031, which participants in this trial may receive, might help treat sudden strokes by reopening blocked blood vessels. In earlier studies, patients found BB-031 safe and easy to handle, even at higher doses, with no serious side effects. Additionally, BB-031 might work beyond the usual time limit for standard stroke treatments, potentially helping more people after a stroke. This suggests BB-031 could become an important option for stroke treatment. ^{1 2 3 5 6}

Who Is on the Research Team?

Michael D Hill, MD

Principal Investigator

University of Calgary

Shahid Nimjee, MD

Principal Investigator

Ohio State University

Are You a Good Fit for This Trial?

This trial is for adults who've had a stroke within the last 24 hours, caused by a blockage in the arteries that supply blood to the front part of their brain. They must be diagnosed with an acute ischemic stroke.

Inclusion Criteria

I started having stroke symptoms less than 24 hours ago.

I have a blockage in the arteries in the front part of my brain.

I have been diagnosed with a stroke caused by a blood clot.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a single dose of either the investigational drug BB-031 or placebo via IV bolus injection

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of radiological outcomes and adverse events

90 days

Multiple visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

• BB-031

Trial Overview The study tests BB-031, a new drug, against a placebo (a substance with no active drug). Participants are randomly chosen to receive either BB-031 or placebo once and will be monitored for three months.

How Is the Trial Designed?

Group I: BB-031 Experimental Treatment 1 Intervention

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

Group II: Placebo Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Basking Biosciences, Inc.

Lead Sponsor

Trials

2

Recruited

200+

Published Research Related to This Trial

The blood-brain barrier (BBB) plays a crucial role in maintaining brain health, and its breakdown is linked to the progression of stroke and other neurodegenerative diseases.

Research is advancing on BBB-targeted therapies that could help protect the brain and promote recovery after a stroke, highlighting the BBB as a key focus for both basic and clinical research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Breaking the barrier in stroke: what should we know? A mini-review. Borlongan, CV., Rodrigues, AA., Oliveira, MC.[2021]

3-n-Butylphthalide (NBP) and its metabolite 3-hydroxy-NBP (3-OH-NBP) can cause significant liver toxicity, with 3-OH-NBP being the most harmful, leading to cell death and oxidative stress in liver cells.

The study suggests that the liver damage from NBP can be mitigated by supplementing with glutathione (GSH) or N-acetylcysteine (NAC), and by avoiding the use of CYP3A4 inducers, which can worsen the toxicity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Site-specific protein modification by 3-n-butylphthalide in primary hepatocytes: Covalent protein adducts diminished by glutathione and N-acetylcysteine. Xue, Y., Ren, X., Zhu, Z., et al.[2021]

In a study of 57 patients with transient ischemic attack or minor stroke, mapping blood-brain barrier dysfunction (BBBD) using dynamic contrast-enhanced MRI revealed significantly higher BBBD in patients compared to healthy controls, indicating its potential as a diagnostic tool.

BBBD mapping not only correlated with clinical symptoms in 72% of patients but also predicted the risk of recurrent stroke, with a risk ratio of 5.35 for those who developed new strokes during follow-up, highlighting its importance for stroke prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blood-Brain Barrier Leakage: A New Biomarker in Transient Ischemic Attacks. Serlin, Y., Ofer, J., Ben-Arie, G., et al.[2020]

In a study of 98 patients with transient ischemic attack (TIA) and positive DWI findings, butylphthalide injection significantly reduced the incidence of cerebral infarction compared to aspirin treatment, indicating its efficacy in preventing stroke.

Butylphthalide injection was found to be safe, with fewer adverse reactions reported, making it a promising option for treating TIA patients at risk of progressing to infarction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of butylphthalide injection on treatment of transient ischemic attack as shown by diffusion-weighted magnetic resonance imaging abnormality. Zhang, C., Zang, Y., Song, Q., et al.[2020]

Trilobatin (TLB) effectively protects the blood-brain barrier (BBB) from disruption caused by cerebral ischaemia-reperfusion injury in a rat model, maintaining BBB integrity and reducing neuronal loss.

TLB works by increasing tight junction proteins and decreasing pro-inflammatory markers, specifically targeting MMP9 and inhibiting the APOE4/CypA/NF-κB pathway, which are crucial for its neuroprotective effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trilobatin attenuates cerebral ischaemia/reperfusion-induced blood-brain barrier dysfunction by targeting matrix metalloproteinase 9: The legend of a food additive. Feng, L., Li, Y., Lin, M., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06226805

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

2. ahajournals.org ahajournals.org/doi/10.1161/str.54.suppl_1.94

Abstract 94: Randomized, Double-blind, Placebo ... Results: BB-031 was safe and well-tolerated for 28 days following single IV doses up to 4.0 mg/kg. There were no significant adverse events ( ...

3. clinicaltrialsarena.com clinicaltrialsarena.com/news/basking-acute-ischemic-stroke-trial/

Basking Biosciences doses first subject in Phase II acute ... “We believe BB-031 will greatly expand the therapeutic options for stroke patients. Recanalisation may also be performed more safely given that ...

4. neurologylive.com neurologylive.com/view/patient-dosing-underway-phase-2-study-rna-aptamer-bb-031-acute-ischemic-stroke

Patient Dosing Underway for Phase 2 Study of RNA ... According to Basking, BB-031 is capable of reopening blocked arteries beyond the therapeutic time window of standard of care, thus potentially ...

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06226805/study-of-bb-031-in-acute-ischemic-stroke-patients-raise

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

6. evtoday.com evtoday.com/news/basking-biosciences-presents-safety-and-dose-escalation-study-for-reversible-thrombolytic-agent-for-ischemic-stroke

Basking Biosciences Presents Safety and Dose-Escalation ... The study found that BB-031 was safe and well tolerated throughout the 28-day study period, with no significant or treatment-emergent adverse ...