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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06226805
Other study ID # BB-031-CLIN-201
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received
Last updated
Start date June 2024
Est. completion date March 2027

Study information

Verified date January 2024
Source Basking Biosciences, Inc.
Contact Program Director
Phone 9196184721
Email snelson@baskingbiosciences.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 participants will be screened for participation after confirmed diagnosis of an anterior circulation ischemic stroke by neurovascular imaging. Enrolled participants will be followed for 90 days. Radiological outcomes will be assessed by a central blinded reviewer. A Data Safety Monitoring Committee will review safety and preliminary efficacy data throughout the study.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 156
Est. completion date March 2027
Est. primary completion date December 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Drug:
BB-031
Solution for injection
Placebo
0.9% sodium chloride for injection

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Basking Biosciences, Inc.

Outcome

Type Measure Description Time frame Safety issue
Other Mortality All-cause mortality 30 days, 90 days
Other Pharmacokinetic (PK) Plasma Level Assessment Plasma levels of study drug 72 hours
Other Pharmacokinetic (PK) Parameter Cmax 72 hours
Other Pharmacodynamic (PD) Assessment Level of free circulating von Willibrand Factor 72 hours
Other Pharmacodynamic (PD) Assessment von Willibrand Factor activity 72 hours
Other Recanalization Proportion of participants with recanalization 6 hours
Other Endovascular Thrombectomy (EVT) Proportion of participants where EVT was not performed due to clinical improvement or evidence of recanalization 6 hours
Other Stroke lesion volume Assessed by MRI or CT 24 hours
Other National Institutes of Health Stroke Scale (NIHSS) Score Change from baseline score (total score 0 to 42, with 0 representing no abnormality 24 hours
Other Modified Rankins Scale (mRS) Score Change from baseline score, where 0=no symptoms and 6=dead Day 90
Other ICU length of stay Duration of ICU stay Up to Day 90
Other Hospitalization length of stay Duration of hospitalization Up to Day 90
Other Successful reperfusion after first pass EVT Proportion of subjects with successful reperfusion after first pass EVT 6 hours
Primary Symptomatic Intracranial Hemorrhage (sICH) Proportion of participants having a sICH 24 hours
Secondary Asymptomatic intracranial hemorrhage (non-symptomatic-ICH) Proportion of participants having a non-symptomatic-ICH 24 hours
Secondary Adverse Events (AEs) Incidence and severity of treatment-emergent AEs 24 hours
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