Y-6 Sublingual Tablets for Acute Penetrating Artery Infarction

NCT07721545 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: Y-6-LC-05
• Study Type: interventional
• Target: 944
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if Y-6 sublingual tablets work to improve functional outcomes in patients with acute perforating artery infarction. It will also learn about the safety of Y-6 sublingual tablets. The main questions it aims to answer are: Does Y-6 sublingual tablets increase the proportion of participants who achieve a modified Rankin Scale (mRS) score of 0-1 at Day 90 after treatment? What medical problems do participants have when taking Y-6 sublingual tablets? Researchers will compare different doses of Y-6 sublingual tablets and placebo to evaluate the effectiveness and safety of Y-6 sublingual tablets in patients with acute perforating artery infarction. Participants will: Take Y-6 sublingual tablets or placebo according to the assigned treatment regimen. Visit the clinic for assessments of neurological function, functional outcomes, and safety during the study period. Complete clinical assessments, including neurological examinations, laboratory tests, and other safety evaluations. Be followed for functional outcomes and safety events after treatment.

Conditions

Perforating Artery Infarction; PAI

Keywords

Y-6; future-2

Outcome Measures

Primary Outcomes (1)

• Proportion of participants achieving a modified Rankin Scale (mRS) score ≤1 after treatment

  The scale ranges from 0 to 6, where a score of 0 indicates no symptoms and a score of 6 indicates death. Higher mRS scores represent greater disability.

  Day 90(+7 days)

Secondary Outcomes (17)

• Distribution of mRS scores after treatment

  Day 90(+7 days)

• Proportion of participants with stroke-related disability after treatment

  Day90 (+7 days)

• Change from baseline in NIHSS (National Institutes of Health Stroke Scale) scores at each assessment time point

  Day90 (+7 days)

• Proportion of participants achieving a Barthel Index score ≥95 after treatment

  Day 90 (+7 days)

• Proportion of participants with early neurological deterioration after treatment

  72 hours (±12 hours) after treatment、Day 7 (±1 day)

Other Outcomes (15)

• Distribution of mRS scores after treatment

  Day 180 (±10 days)、Day 360 (±15 days)

• Proportion of participants with stroke-related disability after treatment

  Day 180 (±10 days)、Day 360 (±15 days)

• Proportion of participants achieving a Barthel Index score ≥95 after treatment

  Day 180 (±10 days)、Day 360 (±15 days)

Study Arms (2)

Y-6 tablet

EXPERIMENTAL

twice daily for 90 consecutive days

Drug: Y-6 tablet

Placebo

PLACEBO COMPARATOR

twice daily for 90 consecutive days

Drug: Placebo

Interventions

Y-6 tablet DRUG

Y-6 sublingual tablets (in accordance with the optimal dose established in stage 1) taken sublingually twice daily for 90 consecutive days.

Y-6 tablet

Placebo DRUG

Placebo (in accordance with the optimal dose established in stage 1) taken sublingually twice daily for 90 consecutive days.

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:

• Male or female participants aged ≥18 and ≤80 years;
• Onset of stroke within 72 hours before the first administration of study treatment;
• Clinical symptoms and signs suggestive of an acute isolated perforating artery territory infarction (no cortical involvement, no multifocal involvement, NIHSS score between 4 and 15, and level of consciousness item 1a ≤1);
• Pre-stroke modified Rankin Scale (mRS) score ≤1 before the current stroke onset;
• Brain magnetic resonance imaging (MRI) diffusion-weighted imaging (DWI) showing an isolated infarction lesion in the perforating artery territory (including the basal ganglia, internal capsule, thalamus, pons, etc.) with a diameter \<30 mm, and meeting at least one of the following criteria:
• The infarct lesion involves at least 3 DWI axial slices;
• The maximum diameter of the lesion on DWI is ≥15 mm;
• The DWI lesion is connected to the ventral surface of the pons, located near the midline, unilateral, and does not cross the midline;
• No severe stenosis of the parent artery supplying the infarct territory (severe stenosis defined as \>70% stenosis on magnetic resonance angiography \[MRA\], or \>50% stenosis on computed tomography angiography \[CTA\] or digital subtraction angiography \[DSA\]);
• The participant or legally authorized representative voluntarily signs the informed consent form approved by the ethics committee.

You may not qualify if:

• Known allergy to any component of the investigational product or its excipients;
• Ischemic stroke caused by large artery atherosclerosis, cardioembolism, arterial dissection, or vasculitis identified at screening;
• History of intracranial hemorrhagic diseases within 3 months prior to screening, including intracerebral hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, subdural hematoma, or epidural hematoma;
• History of other active or major neurological diseases, including recurrent seizures, intracranial tumors, vascular malformations (including arteriovenous malformations, arterial malformations, cavernous malformations), untreated aneurysms \>3 mm in diameter, etc.;
• History of congestive heart failure, or acute myocardial infarction within 3 months prior to screening, or severe cardiac dysfunction (NYHA class III-IV);
• Significant head trauma, intracranial or spinal surgery, or severe physical trauma within 4 weeks prior to screening; major surgery within 3 months prior to screening; or planned endovascular treatment during the study period;
• Severe hepatic or renal dysfunction at screening, or meeting any of the following criteria:
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>3 × upper limit of normal (ULN);
• Estimated glomerular filtration rate (eGFR) \<45 mL/min/1.73 m² (calculated using the CKD-EPI equation based on serum creatinine; see Appendix 4);
• Coagulation disorders, bleeding tendency, or active systemic bleeding at screening, including but not limited to:
• Prothrombin time \>1.5 × ULN;
• Platelet count \<100 × 10⁹/L;
• Hemophilia, capillary fragility disorders, gastrointestinal bleeding, urinary tract bleeding, hemoptysis, vitreous hemorrhage, etc.;
• Persistent systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg despite antihypertensive treatment;
• Known acute gastrointestinal ulcer;

Sponsors & Collaborators

• Neurodawn Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Beijing TianTan Hospital

Beijing, Beijing Municipality, 100070, China

Location

Central Study Contacts

Yilong Wang

CONTACT

13911666571; yilong528@aliyun.com

Study Design

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

Study Record Dates

• First Submitted: July 10, 2026
• First Posted: July 23, 2026
• Study Start (Estimated): August 31, 2026
• Primary Completion (Estimated): February 28, 2028
• Study Completion (Estimated): July 31, 2028
• Last Updated: July 23, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)