LT3001 for Stroke
Recruiting at 1 trial location
CS
Overseen ByClaire Sun
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Lumosa Therapeutics Co., Ltd.
Prior Safety DataThis treatment has passed at least one previous human trial
Trial Summary
What is the purpose of this trial?
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).
Eligibility Criteria
This trial is for individuals who've had a stroke and are eligible for clot removal therapy within 24 hours of symptom onset. They must have a certain severity of stroke, no severe contrast dye allergies, and be able to undergo brain imaging. Women of childbearing age and men with partners of this group must use effective contraception.Inclusion Criteria
I have a blockage in a major brain artery confirmed by a scan.
My MRI or CT scan shows a specific pattern indicating a small area of stroke and significant surrounding at-risk brain tissue.
Subject or subject's legal representative consents to participation by signing the informed consent form (ICF) after receiving full information about the study.
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Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive LT3001 drug product or placebo via intravenous infusion
Single or multiple doses
Follow-up
Participants are monitored for safety and effectiveness after treatment
4-8 weeks
Treatment Details
Interventions
- LT3001 Drug Product
- Placebo
Trial Overview The study tests the safety and effectiveness of LT3001 Drug Product in patients with acute ischemic stroke undergoing endovascular thrombectomy (EVT). Participants will receive either LT3001 or a placebo to see if it improves outcomes after EVT.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: LT3001 Drug ProductExperimental Treatment1 Intervention
Administered by intravenous infusion
Group II: PlaceboPlacebo Group1 Intervention
Administered by intravenous infusion
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Who Is Running the Clinical Trial?
Lumosa Therapeutics Co., Ltd.
Lead Sponsor
Trials
8
Recruited
690+
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