Single, Ascending Dose, First Time in Human Study for GZR18 in Healthy Subjects

Overseen By Kimberly Lazaroff, MSN

Age: 18 - 65

Sex: Male

Trial Phase: Phase 1

Sponsor: Gan and Lee Pharmaceuticals, USA

Must not be taking: Prescription drugs

Disqualifiers: Hepatitis, HIV, Thyroid disease, others

Compensation: Varies

Number of Visits: 1

Duration: 1 day

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. ^{1 2 3 4 5}

Why 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. ^{1 2 4 6 7}

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

Sign and date informed consent prior to any study-related activities being performed

Be considered healthy in the opinion of the PI or qualified designee and have no clinically significant abnormal laboratory values at screening

Have a BMI between 20.0 to 35.0 kg/m2, inclusive, at Screening or check-in prior to dosing

Exclusion Criteria

You have a history of inflammation in your pancreas that has lasted for a long time or occurred suddenly.

The Investigator or qualified designee considers the subject unfit for the study, based on medical interview, physical examination, or laboratory results. Individuals must be free from clinically significant illness or disease, as determined by the PI or qualified designee, with no clinically significant abnormality identified on the medical or laboratory evaluations, including 12-lead ECG

Positive hepatitis-B surface antigen, positive hepatitis-C, or positive HIV test

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single ascending dose of GZR18 or placebo via subcutaneous injection

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

31 days

What Are the Treatments Tested in This Trial?

Interventions

• GZR-18
• Placebo

How Is the Trial Designed?

Group I: Drug:GZR-18 administered via subcutaneous injection Experimental Treatment 1 Intervention

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

Group II: Placebo control Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

Gan and Lee Pharmaceuticals, USA

Lead Sponsor

Trials

27

Recruited

3,200+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06670209

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 ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40028667/

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 ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06777238

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 ...

4. ganlee.com ganlee.com/detail/798.html

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.html

China'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 ...

6. dom-pubs.onlinelibrary.wiley.com dom-pubs.onlinelibrary.wiley.com/doi/abs/10.1111/dom.16285

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-patients

A 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 ...