A Study to Evaluate the Safety and Efficacy of LT3001 Drug Product in Subjects AIS Undergoing EVT

Part of paid clinical trials in Chattanooga, Tennessee.

Sponsor
Lumosa Therapeutics Co., Ltd.
Study ID
NCT05198323
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • LT3001 Drug Product — DRUG
    LT3001 Drug Product administered once by intravenous infusion
  • Placebo — DRUG
    Placebo administered once by intravenous infusion

Study Details

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).

Key Dates

Start date
Aug 11, 2022
Status verified
Jun 2025
Primary completion
Mar 31, 2026
Completion
Mar 31, 2026

Study Design

Enrollment
66 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: LT3001 Drug Product
    Administered by intravenous infusion
  • Placebo Comparator: Placebo
    Administered by intravenous infusion

Primary Outcome Measure

The occurrence of symptomatic intracranial hemorrhage within 24 hours after the single dosing; clinical deterioration defined as an change in the NIHSS of 4 points or more and confirmed by MRI [ Time Frame: Within 24 hours ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
CHI Memorial HospitalChattanoogaTennessee37404
Claire Sun

Find similar trials in Chattanooga, TN

By condition
Stroke
By specialty
NeurologyBrain disorders
By research site
CHI Memorial Hospital· Chattanooga, TN

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