Pharmacokinetic DifferencesPhase 1NCT07055412
Y-3 for Injection in Patients With Hepatic Insufficiency and Healthy Subjects
A Phase 1 study testing Y-3 for injection（40mg） in people with Pharmacokinetic Differences and Y-3, run by Neurodawn Pharmaceutical Co., Ltd..
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetic Differences, Y-3, Saftey
- What is being tested?
- Y-3 for injection（40mg）
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 10 Jul 2025to 31 Dec 2025
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects must meet all of the following criteria for inclusion:
- 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;
- The estimated glomerular filtration rate (eGFR) calculated using the modification of diet in renal disease (MDRD) formula ≥ 80 ml/min/1.73 m2. (See Appendix 2: Glomerular Filtration Rate Calculation Formula);
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- Subjects with hepatic insufficiency must also meet all of the following criteria:
- Chronic liver injury caused by primary liver disease (such as hepatitis B, hepatitis C, autoimmune hepatitis, alcoholic liver disease, non-alcoholic liver disease, fatty liver, etc.) or clinical diagnosis of liver cirrhosis (see Appendix 3: Diagnostic Criteria for Liver Cirrhosis) caused by primary liver disease, Child-Pugh grade A or B patients with hepatic insufficiency (see Appendix 4: Liver Function Assessment for Child-Pugh classification), and have not used albumin within 14 days before screening, and the investigator judged that patients with mild hepatic insufficiency need to be clinically stable ≥for 28 days before taking the investigational products, and patients with moderate hepatic insufficiency need to be clinically ≥stable for 14 days before taking the investigational products, and the investigator judges that the subject's liver function status is stable from 2 weeks before screening to the end of the study, and no obvious deterioration will occur;
- Have not taken any medication within 1 week before screening; or those who require long-term treatment for liver damage, complications and/or other concomitant diseases should have stable medication for at least 4 weeks (stable medication is judged by the investigator, except for drugs prohibited by the protocol).
- Subjects with normal liver function also need to meet all of the following criteria:
- The demographic mean of subjects in the normal hepatic function group (Group C) at screening must meet the following matching standard:
- Sex matching with liver insufficiency group (group A and group B), with a mean value of ±1 case;
- Age matching with hepatic insufficiency group (Group A and Group B) with a mean ± 10 years;
- Body weight matching with hepatic insufficiency group (group A and group B) with a mean of ±10%.
Who cannot join
- Subjects who meet any of the following exclusion criteria will not be eligible for inclusion in this study:
- 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;
- Those who have lost blood or donated ≥ 400 mL of blood within 3 months before dosing, or who have received blood transfusion or used blood products within 1 month, or who plan to donate blood within 1 month after the end of this trial;
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- Those who have used medium or strong inhibitors or inducers of CYP450 enzyme within 1 month before dosing (such as phenytoin, rifampicin, carbamazepine, fluvoxamine, enoxacin, ticlopidine, gemfibrozil, clopidogrel, clarithromycin, itraconazole, ketoconazole, ritonavir, etc., see Appendix 5: List of Common Drugs for CYP Enzyme Inhibitors or Inducers) or UGT enzyme inhibitors or inducers (such as atazanavir, probenecid, valpendict, mefenamic acid, carbamazepine, rifampicin) within 1 month before dosing , phenytoin, efaviren, phenobarbital, ritonavir, etc., see Appendix 6: List of common drugs for UGT enzyme inhibitors or inducers);
- Those who have consumed excessive amounts of tea, coffee and/or caffeinated beverages per day (an average of more than 8 cups per day, 1 cup = 250mL) within 3 months before screening, and those who cannot withdraw during the trial; or those who have consumed a special diet (including dragon fruit, mango, grapefruit, xanthine-rich food, chocolate, etc.) within 2 weeks before screening;
- Those who have participated in other clinical trials and received investigational products within 3 months before screening, or those who plan to participate in other clinical trials during this study;
- Those who are current or previous alcoholics or regular drinkers within 6 months prior to screening, that is, those who drink more than 14 units of alcohol per week (1 unit = 360mL of beer or 45mL of spirits with 40% alcohol or 150mL of wine), or those who have a positive alcohol breath test at baseline (alcohol breath test result >0 mg/100 mL) or those who cannot withdraw during the trial;
- Those with a history of drug abuse or drug use or a positive urine drug screen;
- Those who are cigarette-addict or smoking more than 5 cigarettes per day within 3 months prior to screening or habitual use of nicotine-containing system and are unable to withdraw during the test;
- Those who have received vaccination within 30 days before screening, or plan to be vaccinated during the study;
- Pregnant or lactating women, or women of childbearing age who have a positive blood pregnancy test;
- Patients who have difficulty in venous blood collection and cannot tolerate venipuncture or fainting needles and blood;
- Subjects with poor compliance in the opinion of the investigators, or with other factors that are not suitable for participating in this trial.
- Subjects with hepatic insufficiency who meet any of the following exclusion criteria are excluded:
- Subject has any of the following conditions: drug-induced liver injury, history of liver transplantation, acute liver impairment due to various causes, liver failure complicated by infection and/or hepatic encephalopathy, hepatocellular carcinoma;
- Patients with liver cirrhosis who are considered inappropriate by the investigator, such as hepatorenal syndrome, active bleeding caused by esophageal and gastric variceal rupture, severe/advanced ascites or pleural effusion requiring puncture and drainage and albumin supplementation;
- Patients with primary biliary cirrhosis, biliary obstruction, cholestatic liver disease and other diseases that affect bile excretion;
- Laboratory test results consistent with any of the following at screening: (a) alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 5×ULN; (b) Absolute neutrophil value (NE#) < 0.75×109/L; (c) Hemoglobin (HGB) < 80 g/L;(d) Abnormal alpha-fetoprotein (AFP) value (>100ng/mL) requiring liver ultrasonography or other imaging examinations (CT, MRI, etc.), excluding subjects with suspected hepatocellular carcinoma; (e) Platelet < 50×109/L;
- Those who are screened positive for HIV antibody and Treponema pallidum specific antibody;
- In addition to the primary liver disease itself, those who have suffered from other serious organ system diseases in the past or at present, including but not limited to gastrointestinal, respiratory, renal, neurological, hematologic, endocrine, tumor, immune, psychiatric or cardiovascular and cerebrovascular diseases, which are judged by the research doctor to be unsuitable for participating in this trial;
- Those who have used any prescription medicines, over-the-counter medicines, any vitamin products or Chinese herbal medicines other thanmedicines for the treatment of liver insufficiency or their comorbid chronic diseases within 14 days before administration;
- Systolic blood pressure > 160mmHg or diastolic blood pressure > 100mmHg; Pulse < 50 bpm or > 100 bpm;
- Subjects with normal hepatic function who meet any of the following exclusion criteria are excluded:
- Those who have a history of liver impairment in the past, or those who have and may have liver impairment as indicated by physical examination and laboratory examination at screening;
- Those who have suffered or are currently suffering from any clinical serious diseases such as circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, cardiovascular and cerebrovascular, psychiatric and metabolic abnormalities or any other diseases that can interfere with the test results;
- Those with abnormal physical examination, vital signs, laboratory tests (Hematology, urine routine, blood biochemistry, coagulation function), 12-lead electrocardiogram, chest X-ray (anterior position), abdominal B-ultrasound (liver, spleen, gallbladder, pancreas, and both kidneys) and other examination abnormalities judged by the investigator to be clinically significant;
- Those who test positive for hepatitis B virus surface antigen, hepatitis C virus antibody, HIV antibody, and Treponema pallidum specific antibody;
- Have taken any medication (including prescription medicine, over-the-counter medicine, Chinese herbal medicines, vitamins, health products) within 14 days prior to dosing.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: To Evaluate the Pharmacokinetics and Safety of Y-3 for Injection in Patients With Hepatic Insufficiency and Healthy Subjects
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:
Read more
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
- Being tested
- Y-3 for injection（40mg）
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Y-3 for injection（40mg）Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Y-3（40mg） | Experimental | Not described Receives: Drug: Y-3 for injection（40mg） |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: single-dose administration period (Day1-Day6)
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).
Measured: single-dose administration period (Day1-Day6)
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).
Measured: single-dose administration period (Day1-Day6)
Secondary outcomes (16)
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.
Measured: single-dose administration period (Day1-Day6)
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
Measured: single-dose administration period (Day1-Day6)
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.
Measured: single-dose administration period (Day1-Day6)
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%
Measured: single-dose administration period (Day1-Day6)
Evaluate the Vz 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.
Volume of distribution. Vz = Div/AUC0-∞/λz
Measured: single-dose administration period (Day1-Day6)
Evaluate the CL 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.
Total body clearance. CLz = Div /AUC0-∞
Measured: single-dose administration period (Day1-Day6)
Evaluate the MRT 0-t 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.
Mean residence time within the time from time zero to the lowest testing plasma concentration. MRT0-t = AUMC0-t/AUC0-t.
Measured: single-dose administration period (Day1-Day6)
Evaluate the MRT 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.
Mean residence time extrapolated from zero to infinity. MRT 0-∞ = AUMC 0-∞/AUC 0-∞.
Measured: single-dose administration period (Day1-Day6)
Evaluate the safety of Y-3 (40 mg) in subjects with mild hepatic insufficiency, moderate hepatic insufficiency and gender, age, and weight matching normal hepatic by Incidence of subject getting abnormal results of physical examinations after treatment.
Record changes from baseline to post-treatment, listing deviations from normal ranges post-treatment. Physical examinations will be conduct by the investigator through observation.
Measured: This study comprises a screening period (Day -28 to Day -1), a baseline period (Day -1), a treatment period (Day1 - Day6), and a safety follow-up period (Day10±1).
Evaluate the safety of Y-3 in subjects with mild hepatic insufficiency, moderate hepatic insufficiency and gender, age, and weight matching normal hepatic functionby Incidence of subject getting abnormal results of blood pressure after treatment.
Record changes from baseline to post-treatment, listing deviations from normal ranges post-treatment. blood pressure will be assessed by electronic sphygmomanometer.
Measured: This study comprises a screening period (Day -28 to Day -1), a baseline period (Day -1), a treatment period (Day1 - Day6), and a safety follow-up period (Day10±1).
Evaluate the safety of Y-3 (40 mg) in subjects with mild hepatic insufficiency, moderate hepatic insufficiency and gender, age, and weight matching normal hepatic functionby Incidence of subject getting abnormal results of respiration after treatment.
Record changes from baseline to post-treatment, listing deviations from normal ranges post-treatment. respiration will be assessed by nurses.
Measured: This study comprises a screening period (Day -28 to Day -1), a baseline period (Day -1), a treatment period (Day1 - Day6), and a safety follow-up period (Day10±1).
Evaluate the safety of Y-3 (40 mg) in subjects with mild hepatic insufficiency, moderate hepatic insufficiency and gender, age, and weight matching normal hepatic functionby Incidence of subject getting abnormal results of pulse after treatment.
Record changes from baseline to post-treatment, listing deviations from normal ranges post-treatment. pulse will be assessed by nurses.
Measured: This study comprises a screening period (Day -28 to Day -1), a baseline period (Day -1), a treatment period (Day1 - Day6), and a safety follow-up period (Day10±1).
Evaluate the safety of Y-3 in subjects with mild hepatic insufficiency, moderate hepatic insufficiency and gender, age, and weight matching normal hepatic function by Incidence of subject getting abnormal results of body temperature after treatment.
Record changes from baseline to post-treatment, listing deviations from normal ranges post-treatment. body temperature will be assessed by thermometer.
Measured: This study comprises a screening period (Day -28 to Day -1), a baseline period (Day -1), a treatment period (Day1 - Day6), and a safety follow-up period (Day10±1).
Evaluate the safety of Y-3 (40 mg ) in subjects with mild hepatic insufficiency, moderate hepatic insufficiency and gender, age, and weight matching normal hepatic function by Incidence of subject getting abnormal results of 12-lead ECG after treatment.
Record changes from baseline to post-treatment, listing deviations from normal ranges post-treatment. 12-lead ECG will be analyzed by single RR Heart Rate, aggregate PR Interval, aggregate QRS Duration, aggregate RR Interval, aggregate QT Interval, aggregate QTC Interval. Normal range is provided by the site.
Measured: This study comprises a screening period (Day -28 to Day -1), a baseline period (Day -1), a treatment period (Day1 - Day6), and a safety follow-up period (Day10±1).
Evaluate the safety of Y-3 (40 mg) in subjects with mild hepatic insufficiency, moderate hepatic insufficiency and gender, age, and weight matching normal hepatic function by Incidence of abnormal results of laboratory tests after treatment.
Record changes from baseline to post-treatment, listing deviations from normal ranges post-treatment. Laboratory tests are composed of hematology, urinalysis, serum chemistry, coagulation test. Normal range is provided by the site.
Measured: This study comprises a screening period (Day -28 to Day -1), a baseline period (Day -1), a treatment period (Day1 - Day6), and a safety follow-up period (Day10±1).
Evaluate the safety of Y-3 (40 mg) in subjects with mild hepatic insufficiency, moderate hepatic insufficiency and gender, age, and weight matching normal hepatic function by the rates of adverse events after treatment.
An AE is defined as any untoward medical event that occurs after receiving a drug or treatment or any deterioration of a disease or symptom that existed before receiving the investigational product or treatment (excluding the disease studied in this trial) in a subject or a clinical investigation subject, whether or not considered related to the investigational product or treatment. Therefore, an AE can be a discomfort sign (including an abnormal laboratory finding), symptom, or transient disease beyond any indication, whether or not related to the investigational product or treatment.
The investigator will name each AE reported during the study by MedDRA PT and evaluate their severity using the criteria of "mild", "moderate" and "severe".
The relevance evaluation is divided into 5 grades: 1-certainly related; 2- probably/likely related; 3-possibly related; 4-unlikely related; 5 not related.
Measured: This study comprises a screening period (Day -28 to Day -1), a baseline period (Day -1), a treatment period (Day1 - Day6), and a safety follow-up period (Day10±1).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2025
- Study start10 Jul 2025 (estimated)
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pharmacokinetic DifferencesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neurodawn Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07055412
- Sponsor's protocol ID
- Y-3-LC-07
- Status last verified
- Jun 2025
- First submitted
- 20 Jun 2025
- Last updated
- 8 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate the Pharmacokinetics and Safety of Y-3 for Injection in Patients With Hepatic Insufficiency and Healthy Subjects
- ClinicalTrials.gov ID
- NCT07055412
- Acronym / sponsor ID
- Y-3-LC-07
- Conditions
- Pharmacokinetic Differences, Y-3, Saftey, Mild Hepatic Insufficiency, Moderate Hepatic Insufficiency, Normal Hepatic Function
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Neurodawn Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Jul 2025 (estimated)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 8 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Y-3（40mg） | Experimental | Drug: Y-3 for injection（40mg） |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Subjects must meet all of the following criteria for inclusion:
Key exclusion criteria (31 listed)
- Subjects who meet any of the following exclusion criteria will not be eligible for inclusion in this study:
- Subjects with hepatic insufficiency who meet any of the following exclusion criteria are excluded:
- Subjects with normal hepatic function who meet any of the following exclusion criteria are excluded:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Y-3（40mg） |
Primary outcome
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
Time frame: single-dose administration period (Day1-Day6)
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.
Time frame: single-dose administration period (Day1-Day6)
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.
Time frame: single-dose administration period (Day1-Day6)
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).
16 secondary outcomes
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 frame: single-dose administration period (Day1-Day6)
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.
Time frame: single-dose administration period (Day1-Day6)
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.
Time frame: single-dose administration period (Day1-Day6)
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.
Time frame: single-dose administration period (Day1-Day6)
Evaluate the Vz 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 frame: single-dose administration period (Day1-Day6)
Evaluate the CL 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 frame: single-dose administration period (Day1-Day6)
Evaluate the MRT 0-t 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 frame: single-dose administration period (Day1-Day6)
Evaluate the MRT 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.
Time frame: single-dose administration period (Day1-Day6)
Evaluate the safety of Y-3 (40 mg) in subjects with mild hepatic insufficiency, moderate hepatic insufficiency and gender, age, and weight matching normal hepatic by Incidence of subject getting abnormal results of physical examinations after treatment.
Time frame: This study comprises a screening period (Day -28 to Day -1), a baseline period (Day -1), a treatment period (Day1 - Day6), and a safety follow-up period (Day10±1).
Evaluate the safety of Y-3 in subjects with mild hepatic insufficiency, moderate hepatic insufficiency and gender, age, and weight matching normal hepatic functionby Incidence of subject getting abnormal results of blood pressure after treatment.
Time frame: This study comprises a screening period (Day -28 to Day -1), a baseline period (Day -1), a treatment period (Day1 - Day6), and a safety follow-up period (Day10±1).
Evaluate the safety of Y-3 (40 mg) in subjects with mild hepatic insufficiency, moderate hepatic insufficiency and gender, age, and weight matching normal hepatic functionby Incidence of subject getting abnormal results of respiration after treatment.
Time frame: This study comprises a screening period (Day -28 to Day -1), a baseline period (Day -1), a treatment period (Day1 - Day6), and a safety follow-up period (Day10±1).
Evaluate the safety of Y-3 (40 mg) in subjects with mild hepatic insufficiency, moderate hepatic insufficiency and gender, age, and weight matching normal hepatic functionby Incidence of subject getting abnormal results of pulse after treatment.
Time frame: This study comprises a screening period (Day -28 to Day -1), a baseline period (Day -1), a treatment period (Day1 - Day6), and a safety follow-up period (Day10±1).
Evaluate the safety of Y-3 in subjects with mild hepatic insufficiency, moderate hepatic insufficiency and gender, age, and weight matching normal hepatic function by Incidence of subject getting abnormal results of body temperature after treatment.
Time frame: This study comprises a screening period (Day -28 to Day -1), a baseline period (Day -1), a treatment period (Day1 - Day6), and a safety follow-up period (Day10±1).
Evaluate the safety of Y-3 (40 mg ) in subjects with mild hepatic insufficiency, moderate hepatic insufficiency and gender, age, and weight matching normal hepatic function by Incidence of subject getting abnormal results of 12-lead ECG after treatment.
Time frame: This study comprises a screening period (Day -28 to Day -1), a baseline period (Day -1), a treatment period (Day1 - Day6), and a safety follow-up period (Day10±1).
Evaluate the safety of Y-3 (40 mg) in subjects with mild hepatic insufficiency, moderate hepatic insufficiency and gender, age, and weight matching normal hepatic function by Incidence of abnormal results of laboratory tests after treatment.
Time frame: This study comprises a screening period (Day -28 to Day -1), a baseline period (Day -1), a treatment period (Day1 - Day6), and a safety follow-up period (Day10±1).
Evaluate the safety of Y-3 (40 mg) in subjects with mild hepatic insufficiency, moderate hepatic insufficiency and gender, age, and weight matching normal hepatic function by the rates of adverse events after treatment.
Time frame: This study comprises a screening period (Day -28 to Day -1), a baseline period (Day -1), a treatment period (Day1 - Day6), and a safety follow-up period (Day10±1).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Y-3 for injection（40mg） in people with Pharmacokinetic Differences and Y-3, run by Neurodawn Pharmaceutical Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shuang Li (13938529645, li36918@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: single-dose administration period (Day1-Day6)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2025.