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

NCT07754825 | Not Yet Recruiting Phase 2

• 1 other identifier: SPH-LT3001-207
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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

Outcome Measures

Primary Outcomes (1)

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

  Day 90 after the first dose

Secondary Outcomes (7)

• Proportion of Participants by mRS score (0 - 2)

  Day 30 and Day 90 after the first dose

• Proportion of Participants by mRS score (0 - 1)

  Day 30 after the first dose

• mRS displacement analysis

  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

  Day 30 and Day 90 after the first dose

• Absolute change from baseline in NIHSS score

  Day 3、Day 7、Day 14 and Day 30 after the first dose

Study Arms (3)

LT3001 Drug:high dose

EXPERIMENTAL

Drug: LT3001 Drug:high dose

LT3001 Drug: low dose

EXPERIMENTAL

Drug: LT3001 Drug: low dose

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

LT3001 Drug:high dose DRUG

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

LT3001 Drug:high dose

LT3001 Drug: low dose DRUG

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

LT3001 Drug: low dose

Placebo DRUG

Drug: Placebo Administered by intravenous infusion.

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of acute ischemic stroke that causes evaluable neurological impairment;
• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Shanghai Pharmaceuticals Holding Co., Ltd: lead

Study Sites (1)

Beijing Tiantan Hospital

Beijing, China

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Yongjun Wang

CONTACT

0086-010-59978538; Yongjunwang111@aliyun.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2026
• First Posted: August 10, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 10, 2026

Record last verified: 2026-08

Locations

CN (1)