Actively Recruiting
Bioequivalence Study of GZR18 Injection Before and After CMC Change
Led by Gan & Lee Pharmaceuticals. · Updated on 2026-01-22
138
Participants Needed
1
Research Sites
18 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is an open-label, randomized, single-dose, parallel comparison bioequivalence study conducted in healthy adult male subjects. The study is divided into 3 parts, each of which evaluates the bioequivalence of GZR18 Injection for one strength before and after CMC changes. Subjects eligible for each part of the screening will be randomized into Group A or Group B in a 1:1 ratio. Each subject will receive a single dose of GZR18 Injection, followed by PK blood sampling and safety follow-up for 35 days. Subjects will be admitted to the hospital 1 day predose, follow a standardized light diet that evening, and then fast for at least 10 h thereafter. On the day of administration, GZR18 Injection of a single strength will be administered subcutaneously under fasting conditions at a site approximately two finger-widths (2.5 cm) away from the umbilicus on the abdomen. Lunch and dinner will be served approximately 3 and 9 h postdose, respectively. Venous blood will be collected at 14 time points for GZR18 plasma concentration analysis: at 0 h (within 60 min predose) and 1, 6, 24, 48, 72, 96, 120, 168, 240, 336, 504, 672, and 840 h postdose. Subjects will undergo corresponding laboratory safety tests at screening, D36, and early withdrawal visits. During the entire study period, subjects should maintain a light diet, avoid strenuous exercise, and refrain from consuming juice, caffeinated beverages (such as tea and coffee), and alcoholic drinks. Smoking and any other activities that may affect PK observation or safety evaluations are strictly prohibited.
CONDITIONS
Official Title
Bioequivalence Study of GZR18 Injection Before and After CMC Change
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male subjects aged 18 to 50 years who voluntarily sign the informed consent form
- Weight at least 50 kg and body mass index between 19 and 26 kg/m2
- Able to receive subcutaneous injections and understand the study process and potential adverse reactions
- Subjects of childbearing potential with no plans for fathering a child during the study and willing to use effective contraception
You will not qualify if you...
- Clinically significant abnormalities found during screening physical exam, vital signs, lab tests, ECG, ultrasound, or chest X-ray
- Positive tests for hepatitis B, hepatitis C, HIV, or syphilis
- History or current significant circulatory, urinary, digestive, respiratory, nervous, endocrine, or psychiatric disorders
- History of acute or chronic pancreatitis or pancreatic injury
- History or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2
- Use of drugs altering drug metabolism within 4 weeks before screening or acute illness requiring medication before randomization
- Severe or unexplained infection within 4 weeks before screening
- Major surgery within 6 months before screening or planned surgery or hospitalization during the study
- Known or suspected allergy to the investigational product or its ingredients
- Use of prescription, over-the-counter, or herbal drugs within 2 weeks before screening; use of GLP-1 receptor agonists or similar drugs within 3 months before screening
- Vaccination within 1 month before screening or planned vaccination during the study
- Blood donation or loss of ≥400 mL within 3 months before screening or planned donation during or up to 8 weeks after study
- History or positive test for drug abuse
- History of alcohol abuse or alcohol consumption within 48 hours before administration
- Smoking more than 5 cigarettes per day within 3 months before screening or unwillingness to abstain during study
- Strenuous exercise within 48 hours before dosing or other factors affecting drug absorption or metabolism
- Consumption of grapefruit, caffeine-containing, or xanthine-containing foods or beverages within 48 hours before dosing
- Special dietary requirements or lactose intolerance preventing standardized diet adherence
- History of needle or blood phobia or intolerance to blood collection
- Investigators, study site employees, or their family members
- Participation in another clinical study with an investigational product or device within 3 months before screening or before completing this study
AI-Screening
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Trial Site Locations
Total: 1 location
1
The Second Affiliated Hospital of Soochow University
Suzhou, Suzhou, China
Actively Recruiting
Research Team
X
Xin Zhang Xin Zhang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
6
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