Acute Ischemic StrokePhase 2NCT05686642
Efficacy and Safety of LT3001 on Treating the 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 28 sites in China.
Trial summary
This phase II clinical study is designed to evaluate the safety and efficacy 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
- 28 sitesChina
- Study dates
- 6 Apr 2023to 12 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Subjects aged between 18 and 80 years at screening;
- Clinical diagnosis of acute ischemic stroke that causes evaluable neurological impairment; 3.4 points ≤ NIHSS score ≤ 25 points at randomization;
- 4.Subjects who are able to receive the investigational drug within 24 hours after the onset of stroke; 5.Female subjects of childbearing potential or male subjects 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; 6.All subjects sign the informed consent form by themselves or their guardians after receiving complete study information.
Who cannot join
- Subjects have received or plan to receive endovascular treatment and/or intravenous thrombolytic therapy recommended by Chinese Guidelines for Diagnosis and Treatment of Acute Ischemic Stroke 2018 during this onset period;
- Presence of disturbances of consciousness at screening and NIHSS 1a ≥ 2 points;
- Neurological signs have improved rapidly and spontaneously at screening;
- Subjects who have used or are using protocol-prohibited medications after the onset;
- Subjects with pre-stroke disability;
- Subjects with intracranial hemorrhagic diseases, tumor in brain parenchyma, arteriovenous malformation, aortic arch dissection, other central nervous system lesions that may increase the risk of hemorrhage, or imaging evidence for arterial aneurysm requiring treatment;
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- Massive infarction on imaging;
- Patients who are unable to cooperate due to epileptic seizure at the onset of stroke or other concomitant mental disorders or are unwilling to cooperate;
- 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 subjects, or women of childbearing potential with positive pregnancy test results;
- International normalized ratio > 1.7 or prothrombin time > 15 s;
- Subjects with a history of serious hypersensitivity;
- Subjects who experienced AIS, ICH, acute myocardial infarction or serious head trauma before screening;
- Subjects who underwent any major surgery before screening;
- Subjects with a history of active digestive ulcer before screening;
- Subjects who experienced hemorrhagic disease before screening;
- Subjects who underwent arterial puncture at the site not easy for hemostasis by compression before screening;
- Serious hepatic impairment or serious renal insufficiency;
- Subjects 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
28 sites in 1 country. Contact the study team or a site near you to ask about taking part.
28 sites in 1 country
China28 sites, 28 recruiting
- Recruiting
The First Affiliated Hospital of Baotou Medical College
Baotou, Inner Mongolia, 014017
Bo Liu
- Recruiting
Inner Mongolia Baogang Hospital
Baotou, Inner Mongolia, 750306
Dong Wang
Hongzhe Bei
- Recruiting
Beijing Luhe Hospital Capital Medical University
Beijing, Beijing Municipality, 101199
Yanling Wang, 0086-010-69543901, luhehospital@126.com
- Recruiting
Beijing Tiantan Hospital, Capital Medical University
Beijing, 100070
Yongjun Wang, 0086-010-59978538, Yongjunwang111@aliyun.com
- Recruiting
Beijing Tsinghua Changgung Hospital
Beijing, 102218
Jian Wu, 0086-010-56118567, IRB@btch.edu.cn
- Recruiting
The First Bethune Hospital of Jilin University
Changchun, Jilin, 130061
Yi Yang, 0086-0431-88782013, lunzhijun66@126.com
- Recruiting
Beipiao Central Hospital
Chaoyang, Liaoning, 122199
Yutong Ma, 0086-0421-5080074, chenweihua@sphchina.com
- Recruiting
Daqing Oilfield General Hospital
Daqing, Heilongjiang, 163001
Jianghua Liu, 0086-0459-5804127, ytzyyrenliziyuan@163.com
- Recruiting
The First Affiliated Hospital of Jinan University
Guangzhou, Guangdong, 510630
An'ding Xu, 0086-020-38688366, 2788562962@qq.com
- Recruiting
Zhejiang Hospital
Hangzhou, Zhejiang, 310013
Yaguo Li, 0086-0571-81595231, zjyykjkli@163.com
- Recruiting
Harrison International Peace Hospital
Hengshui, Hebei, 053099
Yan Wei, 0086-0318-2181234, hylq9956@163.com
- Recruiting
Huai'an Second People's Hospital
Huai'an, Jiangsu, 223022
Liandong Zhao, 0086-0517-80871603, haeyxchk@163.com
- Recruiting
Liaocheng People's Hospital
Liaocheng, Shandong, 252004
Cunju Guo, 0086-0635-5099120, lcsrmyywz@163.com
- Recruiting
Linfen Central Hospital
Linfen
Hongguo Dai
- Recruiting
Linfen People's Hospital
Linfen
Junfang Hao
- Recruiting
Luoyang Third People's Hospital
Luoyang, He'nan, 471002
Bing Sun, 0086-0379-63508088, lysyyzxx@163.com
- Recruiting
The Third Hospital of Mianyang
Mianyang, Sichuan
Diwen Zhang
- Recruiting
Nanshi Hospital of Nanyang
Nanyang
Bin Liu
- Recruiting
Pingxiang People's Hospital
Pingxiang, Jiangxi, 337000
Fei Yi, 0086-0799-6882099, pxsrmyyxxk@126.com
- Recruiting
Shanghai Pudong Hospital
Shanghai, 201399
Shuangxing Hou, 0086-021-68036068, pdyyrlb@163.com
- Recruiting
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215004
Chunfeng Liu, 0086-0512-67783686, sdfeyjg@163.com
- Recruiting
Taizhou Municipal Hospital
Taizhou, Zhejiang, 318000
Hao Xu, 0086-0576-88805197, tzmhgcp@163.com
- Recruiting
Taizhou First People's Hospital
Taizhou, Zhejiang, 318020
Zhimin Wang, 0086-0576-84016757, rsk8787@163.com
- Recruiting
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430071
Yumin Liu, 0086-027-67812787, chenweihua@sphchina.com
- Recruiting
Xi'an Gaoxin Hospital
Xi’an, Shanxi, 710077
Yi Jia, 0086-02988332063, gxyyec@163.com
- Recruiting
Yan'an University Xianyang Hospital
Xianyang, Shanxi, 716099
Lei Lei, 0086-029-33779387, ydxygcp@163.com
- Recruiting
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221000
Deqin Geng, 0086-0516-85802291, xyfyec@163.com
- Recruiting
Central People's Hospital of Zhanjiang
Zhanjiang
Hui Mai
About this study
Official title: A Phase II Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Clinical Study to Evaluate the Safety and Efficacy of LT3001 in Subjects With Acute Ischemic Stroke (AIS)
This phase II clinical study is designed to evaluate the safety and efficacy of LT3001 in the treatment of acute ischemic stroke
- Conditions
- Acute Ischemic Stroke
- Being tested
- LT3001 Drug:high dose, Placebo, LT3001 Drug:low dose
- 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
Administered by intravenous infusion.
PlaceboDrug
Administered by intravenous infusion.
LT3001 Drug:low doseDrug
Administered by intravenous infusion.
| Study group | Role | What they receive |
|---|---|---|
| LT3001 Drug:high dose | Experimental | Not described Receives: Drug: LT3001 Drug:high dose |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| LT3001 Drug:low dose | Experimental | Not described Receives: Drug: LT3001 Drug:low dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence Adverse Events
Adverse event type, incidence, duration, correlation with study drug
Measured: Approximately 2 years
Secondary outcomes (4)
Proportion of subjects by mRS（Modified Rankin Scale） score (0 - 2)
Proportion of subjects by mRS score (0 - 2)
Measured: Day 30 and Day 90 after the first dose
Proportion of subjects with an NIHSS（National Institute of Health stroke scale ） score of ≤ 1 point and/or with a decrease of ≥ 4 points from baseline in NIHSS score
Proportion of subjects with an NIHSS score of ≤ 1 point and/or with a decrease of ≥ 4 points from baseline in NIHSS score
Measured: Day 14 after the first dose
Absolute change from baseline in NIHSS score
Absolute change from baseline in NIHSS score
Measured: Day 3、Day 7、Day 14 and Day 30 after the first dose
Proportion of subjects with a BI（Barthel index） score of ≥ 95 points and ≥ 75 points
Proportion of subjects with a BI score of ≥ 95 points and ≥ 75 points
Measured: Day 30 and Day 90 after the first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2023
- Study start6 Apr 2023
- Primary completion10 Dec 2026 (estimated)
- Study completion12 Dec 2026 (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.
- More trials run by Shanghai Pharmaceuticals Holding Co., LtdThe sponsor's other registered studies.
- 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
- NCT05686642
- Sponsor's protocol ID
- SPH-LT3001-202
- Status last verified
- Apr 2026
- First submitted
- 9 Jan 2023
- Last updated
- 30 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Clinical Study to Evaluate the Safety and Efficacy of LT3001 in Subjects With Acute Ischemic Stroke (AIS)
- ClinicalTrials.gov ID
- NCT05686642
- Acronym / sponsor ID
- SPH-LT3001-202
- Conditions
- Acute Ischemic Stroke
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Shanghai Pharmaceuticals Holding Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 6 Apr 2023 (actual)
- Primary completion
- 10 Dec 2026 (estimated)
- Study completion
- 12 Dec 2026 (estimated)
- First posted
- 17 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase II clinical study is designed to evaluate the safety and efficacy of LT3001 in the treatment of acute ischemic stroke
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LT3001 Drug:high dose | Experimental | Drug: LT3001 Drug:high dose |
| Placebo | Placebo comparator | Drug: Placebo |
| LT3001 Drug:low dose | Experimental | Drug: LT3001 Drug:low dose |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects aged between 18 and 80 years at screening;
- Clinical diagnosis of acute ischemic stroke that causes evaluable neurological impairment; 3.4 points ≤ NIHSS score ≤ 25 points at randomization;
- 4.Subjects who are able to receive the investigational drug within 24 hours after the onset of stroke; 5.Female subjects of childbearing potential or male subjects 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; 6.All subjects sign the informed consent form by themselves or their guardians after receiving complete study information.
Key exclusion criteria (23 listed)
- Subjects have received or plan to receive endovascular treatment and/or intravenous thrombolytic therapy recommended by Chinese Guidelines for Diagnosis and Treatment of Acute Ischemic Stroke 2018 during this onset period;
- Presence of disturbances of consciousness at screening and NIHSS 1a ≥ 2 points;
- Neurological signs have improved rapidly and spontaneously at screening;
- Subjects who have used or are using protocol-prohibited medications after the onset;
- Subjects with pre-stroke disability;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LT3001 Drug:high doseAdministered by intravenous infusion. | Drug | LT3001 Drug:high dose |
| PlaceboAdministered by intravenous infusion. | Drug | Placebo |
| LT3001 Drug:low doseAdministered by intravenous infusion. | Drug | LT3001 Drug:low dose |
Primary outcome
Incidence Adverse Events
Time frame: Approximately 2 years
Adverse event type, incidence, duration, correlation with study drug
4 secondary outcomes
Proportion of subjects by mRS（Modified Rankin Scale） score (0 - 2)
Time frame: Day 30 and Day 90 after the first dose
Proportion of subjects with an NIHSS（National Institute of Health stroke scale ） score of ≤ 1 point and/or with a decrease of ≥ 4 points from baseline in NIHSS score
Time frame: Day 14 after the first dose
Absolute change from baseline in NIHSS score
Time frame: Day 3、Day 7、Day 14 and Day 30 after the first dose
Proportion of subjects with a BI（Barthel index） score of ≥ 95 points and ≥ 75 points
Time frame: Day 30 and Day 90 after the first dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
28 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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 28 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yongjun Wang (0086-010-59978538, Yongjunwang111@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence Adverse Events (time frame: Approximately 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.