Your session is about to expire
← Back to Search
Unknown
Single, Ascending Dose, First Time in Human Study for GZR18 in Healthy Subjects
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
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
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Gan and Lee Pharmaceuticals, USALead Sponsor
26 Previous Clinical Trials
3,203 Total Patients Enrolled
Jia Lu, MD/PhDStudy DirectorGan and Lee Pharmaceuticals, USA Corp
Kimberly Lazaroff, MSNStudy DirectorGan and Lee Pharmaceuticals, USA Corp
1 Previous Clinical Trials
19 Total Patients Enrolled