A Study of GZR4 Injection at Different Injection Sites (NCT06548906) | Clinical Trial Compass
RecruitingPhase 1
A Study of GZR4 Injection at Different Injection Sites
China24 participantsStarted 2024-05-08
Plain-language summary
This trial is conducted in China. This study is a randomized, single-center, open, three-period crossover trial in healthy subjects to compare the PK, PD, and safety of a single administration of GZR4 at different injection sites (abdomen, deltoid region of upper arm, and thigh).
Who can participate
Age range
18 Years – 55 Years
Sex
MALE
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:
* 1\. Signing the informed consent form (ICF) before the trial, fully understanding the trial content, process and possible adverse reactions, and being able to comply with the contraindications and restrictions specified in this protocol.
* 2\. A Male adult subjects aged 18-55 years old.
* 3\. Body mass index (BMI) between 19.0-24.0 kg/m2
Exclusion Criteria:
* 1\. Known or suspected hypersensitivity to investigational medical product(s) or related products.
* 2\. Participation in a clinical study of another study drug within 3 months prior to randomization.
* 3\. Physical examination, vital signs, laboratory examination, imaging examination, 12-lead electrocardiogram and other auxiliary examination results that the researchers considered abnormal clinical significance during screening.
* 4\. Donation of blood or blood products (more than 100mL) or significant blood loss (more than 200 mL) within 6 months prior to screening
* 5\. More than 14 units of alcohol per week within 3 months prior to randomization
* 6\. Smoking more than 5 cigarettes per day within 3 months prior to randomization
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
AUC0-672h
Timeframe: From Predose to 672 hours after a single dose