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Y-6 Sublingual Tablets for Acute Penetrating Artery Infarction

NCT07721545 · Status: NOT_YET_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 944

Last updated 2026-07-23

No results posted yet for this study

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

Interventions

DRUG

Y-6 tablet

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

DRUG

Placebo

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

Sponsors & Collaborators

  • Neurodawn Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2028-02-28
Completion
2028-07-31

Countries

  • China

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07721545 on ClinicalTrials.gov