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

24 Participants Needed

Trial Summary

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.

What is the purpose of this trial?

This trial tests a new drug called GZR18 in healthy people. The goal is to see if the drug is safe and well-tolerated. Researchers will also study how the drug behaves in the body and its effects.

Research Team

Kimberly Lazaroff, MSN

Principal Investigator

Gan and Lee Pharmaceuticals, USA Corp

Eligibility Criteria

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

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

Treatment Details

Interventions

• GZR-18
• Placebo

Participant Groups

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+