Single, Ascending Dose, First Time in Human Study for GZR18 in Healthy Subjects
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new drug, GZR-18, to assess its safety and how the body processes it. Researchers will administer different doses of GZR-18 to healthy men through a small injection under the skin. One group will receive GZR-18, while another will receive a placebo, a harmless substance resembling the drug. This study targets men who feel healthy, have normal kidney function, and have not smoked or used alcohol excessively in recent months. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects on people.
Will I have to stop taking my current medications?
Yes, you will need to stop taking any prescription or non-prescription drugs, vitamins, or dietary/herbal supplements at least one week before the study drug is given and until the final follow-up visit.
Is there any evidence suggesting that GZR-18 is likely to be safe for humans?
In earlier studies, GZR18 was well-tolerated by healthy individuals. Research has shown that people from different ethnic backgrounds respond similarly to it, suggesting it is generally well-tolerated across populations.
Detailed information about specific side effects is not yet available, as this phase of the trial is early. The current focus is on safety and determining the correct dose. Testing GZR18 in humans indicates that earlier lab and animal studies found it safe enough to proceed.
Overall, early findings suggest GZR18 is safe for human trials. However, as with any new treatment, more will be learned as additional data is gathered.12345Why do researchers think this study treatment might be promising?
Researchers are excited about GZR-18 because it offers a unique approach by being administered via a subcutaneous injection, potentially allowing for precise dosing and faster absorption. Unlike current treatments that might take oral or intravenous routes, GZR-18's delivery method could improve patient comfort and compliance. Additionally, GZR-18 is being tested in a range of doses, from 1.0 to 50.0 ug/kg, which could help fine-tune its effectiveness and safety profile compared to existing options.
What evidence suggests that GZR-18 could be effective?
Research has shown that GZR-18, which participants in this trial may receive, delivers promising results for weight loss. In one study, participants lost up to 17.8% of their body weight. GZR-18 also helps control blood sugar levels in people with type 2 diabetes. Administered as an injection just under the skin, the treatment remains active in the body for about a week. These early findings suggest that GZR-18 could effectively manage weight and blood sugar.12467
Who Is on the Research Team?
Kimberly Lazaroff, MSN
Principal Investigator
Gan and Lee Pharmaceuticals, USA Corp
Are You a Good Fit for This Trial?
Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single ascending dose of GZR18 or placebo via subcutaneous injection
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- GZR-18
- Placebo
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
For Assigned Interventions: GZR-18 administered once via subcutaneous injection at doses of 1.0 ug/kg, 5.0 ug/kg, 10.0 ug/kg, 20.0 ug/kg, 30.0 ug/kg, 40.0 ug/kg \& 50.0 ug/kg
Commercially obtained sterile, normal saline for injection will be used as the matching placebo. Placebo will be dosed in an identical manner to active study drug. The volume of placebo will be calculated according to body weight using active drug dose for volume calculation in order to maintain the study blind.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Gan and Lee Pharmaceuticals, USA
Lead Sponsor
Citations
A Phase I Clinical Study to Evaluate the Effect of GZR18 ...
This is a single-center, open-label, fixed-sequence phase I clinical study to evaluate the effect of multiple subcutaneous injections of GZR18 ...
The safety, tolerability, pharmacokinetics and ...
The half-life of GZR18 was approximately 7 days in both American and Chinese subjects. Evident body weight reduction was observed in GZR18 ...
NCT06777238 | A Phase III Clinical Study to Evaluate the ...
A Phase III Clinical Study to Evaluate the Efficacy and Safety of GZR18 Injection in Subjects with Type 2 Diabetes Mellitus and Poor Blood Glucose Control by ...
Gan & Lee Pharmaceuticals
Phase 1b/2a Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Bofanglutide (GZR18) Injection in Adult Chinese Patients ...
5.
biopharmaapac.com
biopharmaapac.com/news/116/5506/chinas-gan-lees-gzr18-injection-achieves-up-to-17-8-weight-loss-in-phase-2b-trial.htmlChina's Gan & Lee's GZR18 Injection Achieves Up to 17.8 ...
China's Gan & Lee's GZR18 Injection Achieves Up to 17.8% Weight Loss in Phase 2b Trial ... New data presented at ObesityWeek® 2024 demonstrate the ...
The safety, tolerability, pharmacokinetics and ...
The present studies aimed to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of the ascending dose of GZR18 ...
7.
ctv.veeva.com
ctv.veeva.com/study/a-phase-ii-clinical-trial-to-evaluate-the-efficacy-and-safety-of-gzr18-injection-in-chinese-patientsA Study of GZR18 Injection in Chinese Patients With Type 2 ...
This study was a multicenter, randomized, parallel and controlled study in adult patients with T2DM to evaluate the efficacy, safety (including ...
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