A Study of XY03-EA Tablets in the Treatment of Acute Ischemic Stroke

Summary

The investigators invite participants to participate in a clinical study, which is a multicenter, randomized, double-blind, placebo parallel-controlled phase II.b/III. clinical study to evaluate the efficacy and safety of XY03-EA tablets in the treatment of acute ischemic stroke. After non-clinical pharmacodynamic and pharmacological studies, XY03-EA has a clear effect on the treatment of acute ischemic stroke, with low toxicity and high activity. XY03-EA significantly improves neurological function impaired by cerebral ischemia. In this phase of the study, 360 subjects are planned to be recruited and randomly assigned to four trial groups and placebo groups in a ratio of 1:1:1:1:1.

If participants choose to participate in this trial, participants will be assessed for compliance with the requirements of the study, and participants will be asked to cooperate in completing the screening visit and returning to the hospital within the required time as required by the investigators. During the test, participants will follow the steps described above to have participantsr blood taken for laboratory tests; Participantsr blood sample will be collected at a specified time point for a pharmacokinetic study, and participants will be compensated accordingly. During the study period, participants need to follow the instructions of the study doctor, take the medicine or treatment according to the doctor's instructions, and the doctor will tell participants the time, method, and precautions for the follow-up visit in detail. The main adverse reactions in the clinical trials of XY03-EA tablets are the abnormalities of laboratory examination items, including the increase in alanine aminotransferase, the increase in γ-glutamyl transferase, the increase in aspartate aminotransferase, etc., and the vast majority of AEs are grade 1\~2, which can be recovered without treatment, and there are no serious and uncontrollable adverse events.

If participants experience any discomfort during the study, or new changes in participantsr condition, or any unexpected situation, whether it is related to drugs or not, please inform participantsr study doctor in time, and he/she will make corresponding judgments and treatment according to participantsr condition to protect participantsr health and interests. If an adverse event occurs in a clinical trial, the study physician will take action and determine whether it is related to the trial drug. Participants have the right to withdraw from the trial at any time at any stage without discrimination or retaliation, and participantsr medical treatment and rights will not be affected.

Conditions

• Stroke, Ischemic

Interventions

DRUG

XY03-EA

The sample size was 360 patients, and 72patients were treated with XY03-EA 150 mg, 300mgA group ,300mgBgroup,450mg and placebo respectively. The 150mg group took two tablets of placebo and one tablet of XY03-EA once, three times a day. For 90 days The 300mg A-group took one tablet of placebo and two tablets of XY03-EA once,three times a day. For 90 days The 300mg B-group took one tablet of placebo and two tablets of XY03-EA once,three times a day. Use continuously for 14 days.Placebo is used for 15-90 days. The 450mg group took three tablets of XY03-EA once,three times a day. For 90 days. The placebo group took three tablets of placebo once ,three times a day.For 90 days.

Sponsors & Collaborators

• Shijiazhuang Yiling 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

2024-12-15

Primary Completion

2025-06-30

Completion

2025-12-31

Countries

• China

Study Locations