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.
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.
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 scree…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Clinical diagnosis of acute ischemic stroke * 18 years or older * Anterior circulation intra-cranial occlusion * NIHSS score \>3 * 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 unc…
Interventions
- DrugBB-031
Solution for injection
- DrugPlacebo
0.9% sodium chloride for injection
Locations (24)
- HonorHealth Bob Bove Neuroscience InstituteScottsdale, Arizona
- Mills Peninsula Medical CenterBurlingame, California
- MemorialCare Long Beach Medical CenterLong Beach, California
- California Pacific Medical CenterSan Francisco, California
- Pacific Neurosciences Institute at Saint John's Physician PartnersTorrance, California
- Baptist Health Medical CenterJacksonville, Florida