Acute Ischemic Stroke
Conditions
Brief summary
This is a multicenter, double-blind, single-dose, randomized, and placebo-controlled prospective Phase IIa clinical study, designed to evaluate LT3001 drug product versus placebo/control in subjects with AIS.
Interventions
Active comparator
DRUGPlacebo
Placebo comparator
Sponsors
Lumosa Therapeutics Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* 18 to 90 years * NIHSS of 4 to 30 * Diagnosis of AIS within 24 hours after stroke symptoms onset
Exclusion criteria
* Treatement with approved drug during the current AIS * Pre-stroke disability * Imaging evidence of acute intracranial hemorrhage, intraparenchymal tumor, arteriovenous malformations, other central nervous system lesions that could increase bleeding risk, or aneurysm requiring treatment * Suspected subarachnoid hemorrhage * Seizure * Uncontrolled hypertension * INR \>1.7 and/or abnormal aPTT or platelet count \<100,000/mm3 * Blood glucose concentration \<50 mg/dL or \>400 mg/dL * Lactating or pregnant subjects or those planning to become pregnant during the study * Received anticoagulants and/or antiplatelet therapy and glycoprotein IIb/IIIa inhibitors within 48 hours * AIS, myocardial infarction, serious head trauma or major surgery within 90 days * Bleeding event within 21 days * Puncture of noncompressible vessels within 7 days * Severe hepatic, renal, and/or infectious disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Percentage of Subject Have Symptomatic Intracranial Hemorrhage (sICH) of a Single Dose LT3001 Drug Product in Subjects With AIS. | Within 36 hours | Compare the the percentage of subject having sICH between LT3001 drug product and Placebo. |
Countries
Taiwan, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| LT3001 Drug Product LT3001 Drug Product: Active comparator | 16 |
| Placebo Placebo: Placebo comparator | 8 |
| Total | 24 |
Baseline characteristics
| Characteristic | Placebo | Total | LT3001 Drug Product |
|---|---|---|---|
| Age, Continuous | 67.6 years STANDARD_DEVIATION 9.24 | 63.9 years STANDARD_DEVIATION 11.71 | 62.1 years STANDARD_DEVIATION 12.63 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants | 18 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 5 Participants | 6 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 18 Participants | 15 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 5 Participants | 6 Participants | 1 Participants |
| Sex: Female, Male Female | 1 Participants | 5 Participants | 4 Participants |
| Sex: Female, Male Male | 7 Participants | 19 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 16 | 1 / 8 |
| other Total, other adverse events | 16 / 16 | 7 / 8 |
| serious Total, serious adverse events | 4 / 16 | 2 / 8 |
Outcome results
Primary
The Percentage of Subject Have Symptomatic Intracranial Hemorrhage (sICH) of a Single Dose LT3001 Drug Product in Subjects With AIS.
Compare the the percentage of subject having sICH between LT3001 drug product and Placebo.
Time frame: Within 36 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| LT3001 Drug Product | The Percentage of Subject Have Symptomatic Intracranial Hemorrhage (sICH) of a Single Dose LT3001 Drug Product in Subjects With AIS. | 0 Participants |
| Placebo | The Percentage of Subject Have Symptomatic Intracranial Hemorrhage (sICH) of a Single Dose LT3001 Drug Product in Subjects With AIS. | 0 Participants |