A Phase II Clinical Study of LT3001 for Injection in the Treatment of Acute Ischemic Stroke
NCT07754825
Phase
Phase 2
Recruitment status
Not yet recruiting
Participants
Lead sponsor
Shanghai Pharmaceuticals Holding Co., Ltd
Start date
2026-09-01
Number of sites
- Summary
- This phase II clinical study is designed to evaluate the efficacy and safety of LT3001 in the treatment of acute ischemic stroke
- Short title
- A Phase II Clinical Study of LT3001 for Injection in the Treatment of Acute Ischemic Stroke
- Official title
- A Phase II Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Clinical Study to Evaluate the Efficacy and Safety of LT3001 in Participants With Acute Ischemic Stroke (AIS)
- Control arm
- Placebo
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Not yet recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Completion date
- 2027-12-31
- First posted
- 2026-08-10
- Registry last updated
- 2026-08-10
- Primary completion date
- 2027-12-31
- Start date
- 2026-09-01
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Number of sites
- Registry sponsor category
- Industry
- Lead sponsor
- Shanghai Pharmaceuticals Holding Co., Ltd
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT07754825
- ClinicalTrials.gov ID
- NCT07754825
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- Double masking
- Masked roles
- Participants, Investigators
Sources for study design
Proportion of Participants by mRS（Modified Rankin Scale） score (0 - 1)
Timeframe: Day 90 after the first dose
Proportion of Participants by mRS score (0 - 2)
Timeframe: Day 30 and Day 90 after the first dose
Proportion of Participants by mRS score (0 - 1)
Timeframe: Day 30 after the first dose
mRS displacement analysis
Timeframe: Day 30 and Day 90 after the first dose
Proportion of Participants with an NIHSS score of ≤ 1 point and/or with a decrease of ≥ 4 points from baseline in NIHSS score
Timeframe: Day 30 and Day 90 after the first dose
Absolute change from baseline in NIHSS score
Timeframe: Day 3、Day 7、Day 14 and Day 30 after the first dose
Proportion of Participants with a BI score of ≥ 95 points and ≥ 75 points
Timeframe: Day 30 and Day 90 after the first dose
Incidence Adverse Events
Timeframe: Approximately 2 years
Sources for outcomes
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Maximum age
- 80 Years
- Healthy volunteers
- No
- Clinical diagnosis of acute ischemic stroke that causes evaluable neurological impairment;
- 6 points ≤ NIHSS score ≤ 25 points at randomization;
- Participants who are able to receive the investigational drug within 24 hours after the onset of stroke;
- Female Participants of childbearing potential or male Participants whose sexual partner are women of childbearing potential have no pregnancy plan and voluntarily take effective contraceptive measures during the study period and for 3 months after the last dose;
- All participants sign the informed consent form by themselves or their guardians after receiving complete study information.
- Participants have received or plan to receive endovascular treatment and/or intravenous thrombolytic therapyduring this onset period;
- Presence of disturbances of consciousness at screening and NIHSS 1a ≥ 2 points;
- Neurological signs have improved rapidly and spontaneously at screening;
- Participants who have used or are using protocol-prohibited medications after the onset;
- Participants with pre-stroke disability;
- Imaging evidence of intracranial hemorrhagic diseases, intraparenchymal brain tumor, arteriovenous malformation, aortic arch dissection, other central nervous system lesions that may increase the risk of hemorrhage, or arterial aneurysm requiring treatment;
- Massive infarction on imaging;
- Participants who are unable to cooperate due to epileptic seizure at the onset of stroke or other concomitant mental disorders or are unwilling to cooperate;
- Participants previously diagnosed with concurrent malignant tumors who are currently undergoing anti-tumor treatment or have an expected survival of less than 3 months；
- Systolic blood pressure ≥ 180 mmHg and/or diastolic blood pressure ≥ 100 mmHg after active antihypertensive therapy;
- Acute hemorrhage tendency;
- Blood glucose level < 50 mg/dL or > 400 mg/dL;
- Active visceral hemorrhage;
- Lactating or pregnant Participants, or women of childbearing potential with positive pregnancy test results;
- International normalized ratio > 1.7 or prothrombin time > 15 s;
- Participants with a history of serious hypersensitivity;
- Participants who experienced AIS, ICH, acute myocardial infarction or serious head trauma before screening;
- Participants who underwent any major surgery before screening;
- Participants with a history of active digestive ulcer before screening;
- Participants who experienced hemorrhagic disease before screening;
- Participants who underwent arterial puncture at the site not easy for hemostasis by compression before screening;
- Presence of active hepatitis, cirrhosis, or severe renal insufficiency;
- Participants who have participated in another investigational study and used investigational product before screening;
- Other conditions unsuitable for participation in this study determined by the Investigator.
Sources for eligibility
- Beijing Tiantan HospitalBeijing, China
Sources for sites
Related records
Drugs (2)
Lead sponsors (1)
Conditions (2)
- Ischemic stroke
- Transient ischemic attack Primary condition