Comparing GZR4 Injection at Different Body Sites
A Trial Investigating the Pharmacokinetics, Pharmacodynamics and Safety of GZR4 Injection at Different Injection Regions in Healthy Subjects
This study is testing how well a new injection called GZR4 works and how safe it is when given in the abdomen, upper arm, or thigh to healthy men aged 18-55.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | Male |
| Sponsor | Gan and Lee Pharmaceuticals, USA Industry-sponsored |
| Locations | 1 site (Beijing) |
| Trial ID | NCT06548906 on ClinicalTrials.gov |
What this trial studies
This trial is a randomized, single-center, open-label, three-period crossover study conducted in China, focusing on healthy male adults aged 18-55. It aims to compare the pharmacokinetics (PK), pharmacodynamics (PD), and safety of a single administration of GZR4 injection at three different injection sites: the abdomen, deltoid region of the upper arm, and thigh. Participants will receive the injection at each site in a crossover manner to assess differences in outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy male adults aged 18-55 with a BMI between 19.0-24.0 kg/m2.
Not a fit: Patients with known hypersensitivity to the investigational product or those with significant health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help optimize injection site selection for GZR4, potentially improving patient comfort and treatment efficacy.
How similar studies have performed: While this specific approach is novel, similar studies assessing injection site effects have shown varying degrees of success in optimizing drug delivery.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Beijing
- Study Site — Beijing, China (Recruiting)
Study contacts
- Study coordinator: wei zhao, PhD
- Email: wei.zhao@ganlee.com
- Phone: 01056456746
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.