GZR-18 for Type 2 Diabetes

Phase 1

Waitlist Available

Research Sponsored by Gan and Lee Pharmaceuticals, USA

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 720 hours

Summary

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.

Eligible Conditions

Type 2 Diabetes
Diabetes

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 720 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 720 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 720 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Dose limiting toxicity

Secondary study objectives

Glycosylated Hemoglobin

Maximum Plasma Concentration

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Drug:GZR-18 administered via subcutaneous injectionExperimental Treatment1 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 controlPlacebo Group1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

GZR-18

2022

Completed Phase 1

~30

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