Pharmacokinetic and Safety Study of GZR4 Injection in Subjects With Hepatic Impairment (NCT07193147) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Pharmacokinetic and Safety Study of GZR4 Injection in Subjects With Hepatic Impairment
China36 participantsStarted 2025-10-20
Plain-language summary
This is a multicenter, single-dose, open-label, parallel Phase 1 clinical study to evaluate the PK profile, safety, and tolerability of GZR4 Injection in subjects with mild, moderate, and severe hepatic impairment.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Subjects must fully understand the study contents, study procedures and possible risks and voluntarily sign the informed consent form;
. Male or female subjects aged ≥ 18 years and ≤ 75 years;
. Subjects should have no plans for fertility, sperm, or egg donation during the study and for 8 weeks postdose. They should be willing to use effective contraceptive measures during the study and for 8 weeks postdose, be surgically sterilized, or be female subjects who have reached menopause.
. Only for Subjects with Hepatic Impairment: Subjects with chronic hepatic impairment caused by viral hepatitis, alcoholic liver disease, autoimmune hepatitis, or other reasons;
. Only for Subjects with Hepatic Impairment: Subjects with a prior diagnosis of hepatic cirrhosis confirmed through liver biopsy or other medical imaging techniques;
. Only for Subjects with Hepatic Impairment: Subjects who have not received albumin within 14 days and are classified as Class A, B, or C according to the Child-Pugh score, with hepatic impairment resulting from prior primary liver disorders;
. Only for Subjects with Hepatic Impairment: Subjects with normal or abnormal and not clinically significant vital signs, physical examination, laboratory tests (hematology, blood chemistry, coagulation function and urinalysis), 12-lead ECG, chest X-ray and B-ultrasonography.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Cmax
Timeframe: through study completion, an average of 29 days
2
AUC0-last
Timeframe: through study completion, an average of 29 days
. Subjects with an allergic constitution, including a history of severe drug allergy or drug allergic reactions, who are known to be allergic to the investigational drug or its excipients (glycerol, phenol, m-cresol, zinc acetate dihydrate, sodium chloride, and citric acid monohydrate);
. Subjects with decompensated cardiac failure (NYHA Class III or IV) or those diagnosed with or highly suspected of having unstable angina pectoris or acute myocardial infarction, as well as those with malignant arrhythmias (such as ventricular fibrillation and sustained ventricular tachycardia) within 3 months before screening; subjects with a history of heart valve replacement surgery, coronary artery bypass grafting, or other invasive cardiovascular procedures, including percutaneous coronary intervention, as well as those who have experienced ischemic or hemorrhagic strokes (excluding lacunar infarctions) or transient ischemic attacks within 6 months before screening;
. Subjects with any clinically symptomatic bacterial, viral, parasitic, or fungal infection requiring systemic anti-infective therapy at screening (excluding hepatitis B and C in the hepatic impairment group), those with a history of severe active infection within 1 month before screening, or those who developed any acute infection requiring systemic anti-infective therapy within 2 weeks predose;
. Subjects with a history of drug abuse or drug addiction within 1 year before screening. Additionally, subjects with a positive urine drug abuse screening result predose (that cannot be attributed to concomitant medication) or a positive alcohol screening result;
. Subjects who are heavy smokers or alcohol consumers within 6 months before screening (consuming ≥ 14 units of alcohol per week: 1 unit ≈ 360 mL of beer, 45 mL of spirits, or 150 mL of wine; smoking ≥ 5 cigarettes per day), or those unable to abstain from smoking and alcohol for 48 h predose and during the study;
. Subjects who ingest grapefruit juice, food or beverage rich in methylxanthine (such as coffee, tea, cola, chocolate and functional drinks) within 7 days prior to dosing, or have strenuous exercise and other factors affecting drug absorption, distribution, metabolism and excretion, and cannot withdraw during the study;
. Pregnant or lactating women, women of child-bearing potential (WOCBP) with positive pregnancy test results at screening, or female subjects who have engaged in unprotected sexual intercourse within 2 weeks before screening;
. Subjects who are unwilling or unable to comply with the study procedures specified in the protocol, or who are deemed unsuitable for participating in this clinical study by any investigator.