GZR18 injection pharmacokinetics and safety in people with and without kidney impairment
To Assess the Pharmacokinetic (PK) Differences of GZR18 Injection Between Subjects With Renal Impairment and Those With Normal Renal Function, Providing a Basis for Establishing a Clinical Dosing Regimen for Patients With Renal Impairment
This test will see how a single dose of GZR18 injection is processed and whether it is safe in adults with normal kidney function and in those with mild, moderate, or severe kidney impairment.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Gan & Lee Pharmaceuticals. Industry-sponsored |
| Locations | 1 site (Beijing) |
| Trial ID | NCT07141030 on ClinicalTrials.gov |
What this trial studies
This is a multicenter, single-dose, open-label, parallel Phase 1 trial that measures how GZR18 is absorbed, distributed, metabolized, and excreted and records safety events across groups with different kidney function. Adult participants (18–75 years) meeting weight and BMI criteria will be grouped by renal function (normal, mild, moderate, severe) and receive one dose followed by intensive PK sampling and safety monitoring. Each subject's participation lasts up to 50 days including screening (up to 14 days), an 8-day dosing/observation period, and a 28-day follow-up. The trial aims to define differences in drug exposure and tolerability by level of renal impairment to inform dosing recommendations.
Who should consider this trial
Good fit: Adults aged 18–75 with body weight ≥50 kg, BMI 20–40 kg/m2, and either normal renal function or mild, moderate, or severe renal impairment who can give informed consent are ideal candidates.
Not a fit: People outside the age, weight, or BMI ranges, those who are pregnant or lactating, or those unable to follow protocol restrictions are unlikely to receive benefit from participation.
Why it matters
Potential benefit: If successful, the results could help doctors choose safer, better-informed dosing for people with different levels of kidney function.
How similar studies have performed: Single-dose pharmacokinetic and safety studies in renally impaired populations are a standard, well-established approach and have successfully guided dosing for other medications.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
* 1.Subjects sign the Informed Consent Form (ICF) before the study, fully understand the contents, process and possible adverse reactions of the study, and be able to follow the contraindications and restrictions specified in this protocol.
2.Subjects (male or female) age ≥ 18 and ≤ 75 years at the time of signing ICF.
3.Subjects with childbearing potential from signing the ICF to 8 weeks after the last dose have no family planning, are willing to adopt effective contraceptive measures and have no plans for sperm donation; women of childbearing potential are not pregnant or lactating: they must have a negative pregnancy test at screening and have no unprotected sexual intercourse within 2 weeks before screening.
4.Subjects weighing ≥ 50 kg and 20 ≤ BMI ≤ 40 kg/m2 at screening.
5.Subjects with normal renal function must also meet the following conditions:
1. 90 mL/min ≤ individual's GFR \< 130 mL/min at screening (see Appendix 2: Formulas Involved in the Protocol for the calculation formula).
2. Subjects with normal laboratory test results, vital signs, ECG, physical examination, chest AP view, abdominal B-ultrasound, and other examination results at screening or without clinically significant abnormalities as assessed by the investigator.
6.Subjects with renal impairment must also meet all of the following:
1. Mild renal impairment group: 60 mL/min ≤ individual's GFR \< 90 mL/min at screening; moderate renal impairment group: 30 mL/min ≤ individual's GFR \< 60 mL/min at screening; severe renal impairment group: 15 mL/min ≤ individual's GFR \< 30 mL/min at screening.
2. Subjects with moderate and severe renal impairment should meet the diagnostic criteria for chronic kidney disease (outpatient medical records, hospitalization medical records or laboratory test results can be used as evidence). If the subject is receiving drug therapy, a stable medication regimen (at least within 2 weeks before administration) is required.
Exclusion Criteria:
* 1.Subjects with allergic constitution, including those with a history of severe drug allergy or hypersensitivity reactions, and those known or suspected to be allergic to GLP-1 drugs or their excipients as considered by the investigator.
2.Subjects with a history of acute or chronic pancreatitis and pancreatic injury before screening; subjects with viral hepatitis, alcoholic liver disease, hepatic cirrhosis, autoimmune hepatitis and other liver diseases before screening; subjects with symptomatic gallbladder disease at screening.
3.Subjects who routinely receive dialysis or have a history of kidney transplantation or other organ transplantation before screening.
4.Subjects with severe infection, severe trauma, gastrointestinal surgery, or other major surgical operations within 6 months before screening.
5.Subjects with a history of moderate or major depression, suicidal tendency or suicidal behavior before screening; or other serious mental disorders (schizophrenia, bipolar affective disorder, etc.); or other psychiatric diseases that the investigator considers inappropriate for this study.
6\. Subjects with a history of drug abuse or drug use within 1 year before screening; or subjects with positive result in a drug abuse screening (urine) (which cannot be justified by concurrent medications, such as those used for treating pain, anxiety, or insomnia as complications of renal disorder) at screening.
7.Subjects who have received a vaccine within 2 weeks before screening or are planning to be vaccinated during the study or within 1 month postdose.
8.Subjects who are positive for any indicator of human immunodeficiency virus (HIV) antibody, Treponema pallidum antibody, hepatitis B virus (HBV) surface antigen (HBsAg) or hepatitis C virus (HCV) antibody at screening.
9.Subjects deemed unsuitable for inclusion by the investigator for other reasons.
Where this trial is running
Beijing
- Gan & Lee Pharmaceuticals — Beijing, China (Recruiting)
Study contacts
- Study coordinator: Li yuan Zhao, Ph.D
- Email: liyuan.zhao@ganlee.com
- Phone: 010-8059-5000
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.