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.
The subject fully understands the purpose and requirements of this trial, voluntarily participates in the clinical trial and signs a written ICF, strictly abide by the clinical study protocols and requirements to complete the whole study process;
Be 18~70 years old (including the boundary value) on the day of signing the ICF, both male and female;
At screening, the weight of male subjects ≥ 50kg, the weight of female subjects ≥ 45kg, and the body mass index [BMI=Weight (kg)/height 2 (m2)] within the range of 18.0~30.0kg/m2 (including boundary value);
Subjects (including their spouses or partners) have no sperm or egg donation programs, no fertility plans, and voluntary strict contraceptive use during the trial and within 3 months after the completion of the trial, see Appendix 1: Contraceptive measures administration and contraceptive requirements;
Irritable the physique, such as those with a known history of allergy to two or more substances, or those with allergic diseases, or those with a history of allergy to investigational products or excipients (15-hydroxystearate polyethylene glycol, propylene glycol, potassium dibasic phosphate, potassium dibasic phosphate trihydrate, mannitol);
Those who have special dietary requirements and cannot comply with the uniform diet;
Patients with clinically significant ECG abnormalities (tachycardia/bradycardia, II-III degree atrioventricular block or QTcF interval prolongation (QTcF>450ms for males and >470ms for females) (corrected according to Fridericia's formula: QTcF=QT/(RR^0.33), RR=60/heart rate) or other clinically significant abnormalities judged by the investigator to be unsuitable for participating in this study);
Those who have serious infection, trauma, gastrointestinal surgery or other surgical procedures within 4 weeks before screening, or those who plan to undergo surgical treatment during the trial or have a tendency to be hospitalized;
Single group
Y-3 for injection（40mg）
DrugThe 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.
Evaluate the Cmax of Y-3 (40 mg ) in subjects with mild hepatic insufficiency , moderate hepatic insufficiency and gender, age, and weight matching normal hepatic function by venous blood and Phoenix WinNonlin
Maximum observed plasma concentration. It was obtained directly from the measured plasma concentration-time data.
Evaluate the AUC 0-t of of Y-3 (40 mg ) in subjects with mild hepatic insufficiency , moderate hepatic insufficiency and gender, age, and weight matching normal hepatic function by venous blood and Phoenix WinNonlin.
Area under the concentration-time curve from time 0 to the time of the last quantifiable concentration. Calculated according to linearity trapezoidal rule: AUC (i, i+1) = (Ti+1-Ti) (Ci+Ci+1) /2, and AUC0-t is the sum of all AUC (i, i + 1).
Evaluate the AUC 0-∞ of Y-3 (40 mg) in subjects with mild hepatic insufficiency , moderate hepatic insufficiency and gender, age, and weight matching normal hepatic function by venous blood and Phoenix WinNonlin.
Area under the concentration-time curve from time 0 to infinity (extrapolated). AUC 0-∞ =AUC 0-t + Ct/λz (Ct is the last measured plasma concentration).
Evaluate the Tmax of Y-3 (40 mg ) in subjects with mild hepatic insufficiency , moderate hepatic insufficiency and gender, age, and weight matching normal hepatic function by venous blood and Phoenix WinNonlin.
Time to reach maximum observed plasma concentration. It was obtained directly from the measured plasma concentration-time data.
Evaluate the t1/2 of Y-3 (40 mg ) in subjects with mild hepatic insufficiency, moderate hepatic insufficiency and gender, age, and weight matching normal hepatic function by venous blood and Phoenix WinNonlin.
Terminal elimination half-life. t1/2 = ln2/λ
Evaluate the λz of Y-3 (40 mg ) in subjects with mild hepatic insufficiency, moderate hepatic insufficiency and gender, age, and weight matching normal hepatic function by venous blood and Phoenix WinNonlin.
Terminal-phase elimination rate constant, slope of curves terminal segment at semi-log concentration-time curve calculated by linear regression.
Evaluate the AUC_%Extrap of Y-3 (40 mg ) in subjects with mild hepatic insufficiency, moderate hepatic insufficiency and gender, age, and weight matching normal hepatic function by venous blood and Phoenix WinNonlin.
The percentage of the AUC0-inf that has been extrapolated. AUC\_%Extrap = \[(AUC0-∞-AUC0-t)/AUC0-∞\] × 100%
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