Acute Ischemic StrokePhase 2NCT07754825
A Phase II Clinical Study of LT3001 for Injection in the Treatment of Acute Ischemic Stroke
A Phase 2 study testing LT3001 Drug:high dose and LT3001 Drug: low dose in people with Acute Ischemic Stroke, run by Shanghai Pharmaceuticals Holding Co., Ltd at 1 site in China.
Trial summary
This phase II clinical study is designed to evaluate the efficacy and safety of LT3001 in the treatment of acute ischemic stroke Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- LT3001 Drug:high dose and LT3001 Drug: low dose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2026to 31 Dec 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 24Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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)
This phase II clinical study is designed to evaluate the efficacy and safety of LT3001 in the treatment of acute ischemic stroke
- Conditions
- Acute Ischemic Stroke
- Being tested
- LT3001 Drug:high dose, LT3001 Drug: low dose, Placebo
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LT3001 Drug:high doseDrug
Drug: LT3001 Drug:high dose Administered by intravenous infusion.
LT3001 Drug: low doseDrug
Drug: LT3001 Drug: low dose Administered by intravenous infusion.
PlaceboDrug
Drug: Placebo Administered by intravenous infusion.
| Study group | Role | What they receive |
|---|---|---|
| LT3001 Drug:high dose | Experimental | Not described Receives: Drug: LT3001 Drug:high dose |
| LT3001 Drug: low dose | Experimental | Not described Receives: Drug: LT3001 Drug: low dose |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants by mRS（Modified Rankin Scale） score (0 - 1)
Measured: Day 90 after the first dose
Secondary outcomes (7)
Proportion of Participants by mRS score (0 - 2)
Measured: Day 30 and Day 90 after the first dose
Proportion of Participants by mRS score (0 - 1)
Measured: Day 30 after the first dose
mRS displacement analysis
Measured: Day 30 and Day 90 after the first dose
Proportion of Participants with an NIHSS(National Institutes of Health Stroke Scale) score of ≤ 1 point and/or with a decrease of ≥ 4 points from baseline in NIHSS score
Measured: Day 30 and Day 90 after the first dose
Absolute change from baseline in NIHSS score
Measured: Day 3、Day 7、Day 14 and Day 30 after the first dose
Proportion of Participants with a BI(Barthel Index) score of ≥ 95 points and ≥ 75 points
Measured: Day 30 and Day 90 after the first dose
Incidence Adverse Events
Measured: Approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study start1 Dec 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Pharmaceuticals Holding Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07754825
- Sponsor's protocol ID
- SPH-LT3001-207
- Status last verified
- Aug 2026
- First submitted
- 5 Aug 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No