A Phase II, Two-Part, Double-Blind, Randomized, Placebo Controlled Study to Evaluate the Safety and Efficacy of LT3001 Drug Product in Subjects With Acute Ischemic Stroke (AIS) Undergoing Endovascular Thrombectomy (EVT)
Lumosa Therapeutics Co., Ltd.
Summary
A phase IIb clinical study to evaluate the safety and efficacy of single or multiple doses of LT3001 drug product in subjects with acute ischemic stroke (AIS) undergoing endovascular thrombectomy (EVT).
Description
This is a 2-part, multicenter, double-blind, randomized, and placebo-controlled prospective Phase II clinical study, designed to evaluate LT3001 drug product versus placebo in subjects with AIS undergoing EVT. Subjects who participate in this trial should be treated with standard of care (SoC) of AIS therapies when appropriate.
Eligibility
- Age range
- 18–90 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Subject or subject's legal representative consents to participation by signing the informed consent form (ICF) after receiving full information about the study. 2. Subject is aged 18 to 90 years, inclusive, at the time of Screening (Visit 1). 3. Subject has an NIHSS ≥6. 4. Subject is eligible to be treated with EVT within 24 hours after stroke symptoms onset. Subject has no severe contrast allergy or absolute contraindication to iodinated contrast preventing EVT, including any contraindications listed in the prescribing information approved by local regulatory authoriti…
Interventions
- DrugLT3001 Drug Product
LT3001 Drug Product administered once by intravenous infusion
- DrugPlacebo
Placebo administered once by intravenous infusion
Locations (2)
- CHI Memorial HospitalChattanooga, Tennessee
- Taichung Medical UniversityTaichung