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Not yet recruitingNCT07754825Updated Oct 19, 2026

A Phase II Clinical Study of LT3001 for Injection in the Treatment of Acute Ischemic Stroke

A Phase 2 interventional study of LT3001 Drug:high dose and LT3001 Drug: low dose in Acute Ischemic Stroke, sponsored by Shanghai Pharmaceuticals Holding Co., Ltd. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-19.

Sponsored by Shanghai Pharmaceuticals Holding Co., Ltd · Phase 2, Interventional, and Treatment

Updated Oct 19, 2026Start date movedGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 746 studies in Ischemic Stroke with a site in China — 373 open to participants now, 392 under way, 75 of them phase 3. Ischemic Stroke · China.

Planned enrollment
255th of 560
300 · median 263
Started
2026
with 118 others
Phase 2
71 of 746
29 open now
Primary completion
2027-12
later than 254 of 391 live
Registered
720th of 746
by date

Among the 746 studies in Ischemic Stroke with a site in China, this one is the 255th largest by planned enrollment of the 560 interventional ones that give a count, is one of 119 that started in 2026, is one of 71 in phase 2, reaches primary completion later than 254 of the 391 other live ones, and was the 720th registered.

Ischemic Stroke

2,612 studies on the registry are indexed under Ischemic Stroke; 971 are open to participants now.

Browse Ischemic Stroke studies →

Open to participants now

373 of the 746 studies in Ischemic Stroke with a site in China are open now. Recruiting first, the newest first:

368 more — sign in →

All 373 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 655 Ischemic Stroke studies recruiting now, 394 (60%) set no upper age limit and 62 (9%) stop at 75 or younger; 26 take children under 18; 41 take healthy volunteers.

This study: 18 Years to 80 Years · all sexes · no healthy volunteers.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 746 studies in Ischemic Stroke with a site in China, or all of them as a file.
02

Study summary

This phase II clinical study is designed to evaluate the efficacy and safety of LT3001 in the treatment of acute ischemic stroke

03

Conditions studied

  • Acute Ischemic Stroke

Browse trials for

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Clinical diagnosis of acute ischemic stroke that causes evaluable neurological impairment;
  2. 6 points ≤ NIHSS score ≤ 25 points at randomization;
  3. Participants who are able to receive the drug within 24 hours after the onset of stroke;
  4. Female Participants of or male Participants whose sexual partner are women of childbearing potential have no pregnancy plan and voluntarily take effective measures during the study period and for 3 months after the last dose;
  5. All participants sign the form by themselves or their guardians after receiving complete study information.

Exclusion criteria

Exclusion Criteria:

  1. Participants have received or plan to receive endovascular treatment and/or intravenous thrombolytic therapyduring this onset period;
  2. Presence of disturbances of consciousness at screening and NIHSS 1a ≥ 2 points;
  3. Neurological signs have improved rapidly and spontaneously at screening;
  4. Participants who have used or are using protocol-prohibited medications after the onset;
  5. Participants with pre-stroke disability;
  6. 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;
  7. Massive infarction on imaging;
  8. 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;
  9. Participants previously diagnosed with concurrent malignant tumors who are currently undergoing anti-tumor treatment or have an expected survival of less than 3 months；
  10. Systolic blood pressure ≥ 180 mmHg and/or diastolic blood pressure ≥ 100 mmHg after active antihypertensive therapy;
  11. Acute hemorrhage tendency;
  12. Blood glucose level \< 50 mg/dL or > 400 mg/dL;
  13. Active visceral hemorrhage;
  14. Lactating or pregnant Participants, or women of with positive pregnancy test results;
  15. > 1.7 or prothrombin time > 15 s;
  16. Participants with a history of serious ;
  17. Participants who experienced AIS, ICH, acute myocardial infarction or serious head trauma before screening;
  18. Participants who underwent any major surgery before screening;
  19. Participants with a history of active digestive ulcer before screening;
  20. Participants who experienced hemorrhagic disease before screening;
  21. Participants who underwent arterial puncture at the site not easy for hemostasis by compression before screening;
  22. Presence of active hepatitis, cirrhosis, or severe renal insufficiency;
  23. Participants who have participated in another study and used investigational product before screening;
  24. Other conditions unsuitable for participation in this study determined by the Investigator.
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
300 participants (estimated)

Study arms

  • Experimental
    LT3001 Drug:high dose

    Drug: LT3001 Drug:high dose

  • Experimental
    LT3001 Drug: low dose

    Drug: LT3001 Drug: low dose

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

  • DrugLT3001 Drug:high dose

    Drug: LT3001 Drug:high dose Administered by intravenous infusion.

  • DrugLT3001 Drug: low dose

    Drug: LT3001 Drug: low dose Administered by intravenous infusion.

  • DrugPlacebo

    Drug: Placebo Administered by intravenous infusion.

06

What researchers measure

Primary outcomes

  1. Proportion of Participants by mRS（Modified Rankin Scale） score (0 - 1)

    Time frame: Day 90 after the first dose

Secondary outcomes

  1. Proportion of Participants by mRS score (0 - 2)

    Time frame: Day 30 and Day 90 after the first dose

  2. Proportion of Participants by mRS score (0 - 1)

    Time frame: Day 30 after the first dose

  3. mRS displacement analysis

    Time frame: Day 30 and Day 90 after the first dose

  4. 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

    Time frame: Day 30 and Day 90 after the first dose

  5. Absolute change from baseline in NIHSS score

    Time frame: Day 3、Day 7、Day 14 and Day 30 after the first dose

  6. Proportion of Participants with a BI(Barthel Index) score of ≥ 95 points and ≥ 75 points

    Time frame: Day 30 and Day 90 after the first dose

  7. Incidence Adverse Events

    Time frame: Approximately 2 years

07

Study locations

1 site
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Dec 2026; primary completion for Dec 2027, 12 months later.

Of 41 industry-sponsored phase 2 interventional studies under Ischemic Stroke, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 35. This study's planned 12 months is below that.

Counting every sponsor, half of 124 studies reached it within 28 months; a quarter within 15 and three quarters within 39.

Start moved once since we started tracking on Sep 25, 2026: Sep 2026 → Dec 2026, on Oct 19, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Aug 5, 2026
First posted
Aug 10, 2026
StartEst.
Dec 1, 2026was Sep 2026
Primary completionEst.
Dec 31, 2027
CompletionEst.
Dec 31, 2027
Last update
Oct 19, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Start date
Sep 1, 2026→Dec 1, 2026
Oct 19, 2026
Secondary outcomes
2 edited
What changed in the outcomes
  • EditedProportion 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 scoreTime frame: Day 30 and Day 90 after the first dose
  • EditedProportion of Participants with a BI(Barthel Index) score of ≥ 95 points and ≥ 75 pointsTime frame: Day 30 and Day 90 after the first dose
Oct 19, 2026
Show all 1 update
  1. Oct 19, 2026
    Start date Sep 1, 2026→Dec 1, 2026
    Secondary outcomes 2 edited
    What changed in the outcomes
    • EditedProportion 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 scoreTime frame: Day 30 and Day 90 after the first dose
    • EditedProportion of Participants with a BI(Barthel Index) score of ≥ 95 points and ≥ 75 pointsTime frame: Day 30 and Day 90 after the first dose

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07754825
Lead sponsor
Shanghai Pharmaceuticals Holding Co., Ltd
Responsible party
Sponsor
First posted
Aug 10, 2026
Start date
Dec 1, 2026 (estimated)
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Oct 19, 2026

Study contacts

Yongjun Wang
Contact
Yongjunwang111@aliyun.com
0086-010-59978538

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Studies of the drug tested here: LT3001

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