Search / Trial NCT06226805

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

Launched by BASKING BIOSCIENCES, INC. · Jan 17, 2024

Trial Information

Current as of October 07, 2024

Recruiting

Keywords

Stroke Wake Up Stroke Large Vessel Occlusion Intracranial Hemorrhage

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 participa...

Gender

ALL

Eligibility criteria

  • 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

About Basking Biosciences, Inc.

Basking Biosciences, Inc. is an innovative clinical trial sponsor dedicated to advancing healthcare through the development of novel therapeutics and cutting-edge biotechnologies. With a focus on addressing unmet medical needs, the company leverages a robust pipeline of drug candidates targeting various disease areas, including oncology and rare diseases. Basking Biosciences is committed to conducting rigorous clinical research while adhering to the highest standards of regulatory compliance and ethical practices. Through strategic collaborations and a patient-centered approach, the company aims to bring transformative solutions to patients and improve outcomes in the healthcare landscape.

Locations

Toledo, Ohio, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0