Actively Recruiting
Study of Pharmacokinetics and Safety of GZR18 Injection in Subjects With Liver Insufficiency and Normal Liver Function
Led by Gan & Lee Pharmaceuticals. · Updated on 2025-08-27
24
Participants Needed
1
Research Sites
76 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study adopts a multicenter, single-dose, open-label, and parallel design, which is aimed at assessing the PK and safety profiles of GZR18 Injection in subjects with normal liver function and those with mild, moderate or severe liver insufficiency. The study duration for each subject in this study is up to 50 days, including a screening period of up to 14 days (Day-14 to Day-1), an 8-day dosing/observation period (Day 1 to Day 8), and a 28-day follow-up period (Day 9 to Day 36).
CONDITIONS
Official Title
Study of Pharmacokinetics and Safety of GZR18 Injection in Subjects With Liver Insufficiency and Normal Liver Function
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects who understand the study, procedures, risks, and voluntarily sign informed consent
- Male or female subjects aged 18 to 75 years at informed consent signing
- Weight of at least 50 kg for males and 45 kg for females, with BMI between 19.0 and 32.0 kg/m2
- Subjects with childbearing potential must use effective contraception from consent to 8 weeks after last dose, have negative pregnancy test at screening, and no unprotected sex within 2 weeks before screening
- For liver insufficiency subjects: chronic liver insufficiency from viral hepatitis, alcoholic liver disease, autoimmune hepatitis, or other causes without rapid disease progression
- Liver insufficiency subjects classified as Child-Pugh grade A, B, or C, with no albumin use within 21 days before screening
- Physical condition suitable as determined by medical history, physical exam, vital signs, lab tests, ECG, chest X-ray, and ultrasound
- For normal liver function subjects: matched with liver insufficiency group by age, sex, weight, and BMI
- Normal or clinically insignificant abnormal results in lab tests, vital signs, exams, ECG, chest X-ray, and ultrasound
You will not qualify if you...
- History of severe drug hypersensitivity or allergy to investigational drug or its components (citrate, sodium chloride, disodium hydrogen phosphate, hydrochloric acid, sodium hydroxide)
- History of acute or chronic pancreatitis or pancreatic injury, or symptomatic gallbladder disorders at screening
- History or family history of medullary thyroid carcinoma or multiple endocrine neoplasia 2A or 2B
- Cardiovascular or cerebrovascular diseases within 6 months before screening including severe cardiac insufficiency (NYHA Class III or IV), unstable angina, myocardial infarction, heart valve surgery, coronary artery bypass, percutaneous coronary intervention, stroke, or transient ischemic attack
- QTcF interval > 470 msec for males or > 480 msec for females on ECG at screening
- History of severe active infection within 1 month before screening
- History of malignant tumors within past 5 years except certain skin or cervical in situ cancers
- Severe trauma, gastrointestinal surgery, or major surgery within 4 weeks before screening
- Unwilling or unable to comply with study procedures or deemed unsuitable by investigators
AI-Screening
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Trial Site Locations
Total: 1 location
1
Gan & Lee Pharmaceuticals
Beijing, China
Actively Recruiting
Research Team
L
Li yuan Zhao, Ph.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
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