NCT06226805

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

Name: Clinical Trial NCT06226805
Creator: Basking Biosciences, Inc.
Keywords: Acute Ischemic Stroke, BB-031, Phase 2, drug, clinical trial

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

Basking Biosciences, Inc.·Phase 2·ClinicalTrials.gov·drugNot yet recruiting

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Study focus

Disease/Condition: Acute Ischemic Stroke
Drug/Device/Intervention: BB-031
Study type: Interventional
Intervention type: drug

Sponsor & location

Primary sponsor: Basking Biosciences, Inc.

Timeline & enrollment

Phase: Phase 2
Start date: Jun 01, 2024
End date: Mar 01, 2027
Enrollment: 156 participants

Primary outcome

Symptomatic Intracranial Hemorrhage (sICH)

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 156 patients are planned in this study.

ICD-10 classifications

Stroke, not specified as haemorrhage or infarctionSequelae of stroke, not specified as haemorrhage or infarctionCerebral infarctionCerebral infarction, unspecifiedTransient cerebral ischaemic attack, unspecified

Data source

Registry: ClinicalTrials.gov
Trial ID: NCT06226805
Type: Non-Device Trial

About this record

Access comprehensive clinical trial information for NCT06226805 through Pure Global AI's free database. This Phase 2 trial is sponsored by Basking Biosciences, Inc. and is currently Not yet recruiting. The study focuses on Acute Ischemic Stroke. Target enrollment is 156 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.