Y-3 for Injection in Patients With Hepatic Insufficiency and Healthy Subjects

Summary

The goal of this clinical trial is to assess the pharmacokinetic profiles and safety of Y-3 in subjects with mild hepatic insufficiency (Child-Pugh: grade A), moderate hepatic insufficiency (Child-Pugh: grade B) and gender, age, and weight matching normal hepatic function, so as to provide a scientific basis for rational clinical medication in patients with hepatic insufficiency.

The main questions it aims to answer are:

What the pharmacokinetic profiles of Y-3 (40 mg ) in subjects with mild hepatic insufficiency (Child-Pugh: grade A), moderate hepatic insufficiency (Child-Pugh: grade B) and gender, age, and weight matching normal hepatic function？ If drug Y-3 (40mg ) is safe and tolerate in subjects with mild hepatic insufficiency (Child-Pugh: grade A), moderate hepatic insufficiency (Child-Pugh: grade B) and gender, age, and weight matching normal hepatic function.

Investigators will compare pharmacokinetic safety profiles of Y-3 (40 mg ) in subjects with different hepatic functions( mild hepatic insufficiency, moderate hepatic insufficiency, normal.

Participants will:

Take drug Y-3 (40 mg) only once. Answer questions regarding your medical history. Comply with the study procedures and requests. Complete all tests and collections of PK Sampling. Fasting for more than 10 hours before administration, water abstinence for 1 h before and after administration, and eating standard lunch and dinner 4 hours and 10 hours after starting administration.

Must not use of nicotine-containing products (including nicotine patches). Must not do strenuous exercise for 1 hour before each clinical laboratory test blood draw. Subjects may engage in light recreational activities for the duration of the study.

Follow your doctor's instructions, answer the investigator's questions about your health status truthfully, and cooperate with the test-related tests.

During the experiment, the test should be completed in strict accordance with the requirements of the investigator, and the test-related work such as drug administration and sample collection should be conscientiously cooperated, and the research center should not leave the research center without authorization, and the rules and regulations of the research center and the investigator 's propaganda and education should be observed. Any medication taken should be reported truthfully.

Must come to the hospital at the agreed follow-up time with the investigator and you.

Inform the investigator or relevant person about any changes in your health status, including any favorable or unfavorable changes.

Must not participate in any other drug clinical trials during this trial. Must tell your investigator about all medical treatments you plan to receive during the study, such as elective surgery or radiation therapy.

In addition to yourself, at least one member of your family is expected to be aware of the clinical research you will be involved in and care about your health, and will be able to provide feedback to your doctor about your health during follow-up visits. Your family should promptly notify your study physician if you become seriously unwell, including hospitalization for treatment.

Notify your investigator if your address, phone number, or other contact information changes.

Must not use medications that may interfere with PK or safety.

Conditions

• Pharmacokinetic Differences
• Y-3
• Saftey
• Mild Hepatic Insufficiency
• Moderate Hepatic Insufficiency
• Normal Hepatic Function

Interventions

DRUG

Y-3 for injection（40mg）

The investigational drug (Y-3) consists of two parts: Y-3 for injection (lyophilized powder) and Solvent for Y-3 for injection (concentrated solution). Name: Y-3 for injection Strength: 20 mg Dosage Form: Lyophilized powder for injection Storage Condition: 2-8°C Supplier: Neurodawn Pharmaceutical Co., Ltd. Name: Reconstitution diluent for Y-3 for injection Strength: 3ml (containing 0.6 g propylene glycol) Dosage Form: Concentrated solution for injection Storage Condition: 2-8°C Supplier: Neurodawn Pharmaceutical Co., Ltd.

Sponsors & Collaborators

• Neurodawn Pharmaceutical Co., Ltd.

  lead INDUSTRY

Study Design

Allocation

NA

Purpose

OTHER

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-07-10

Primary Completion

2025-10-31

Completion

2025-12-31