NCT05328726

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

A Double-blind, Randomized, Placebo-controlled, Sequential, Single, Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Parameters of Subcutaneous Injections of GZR18 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Gan and Lee Pharmaceuticals, USA · Industry
• Sex: Male
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

Single ascending dose first time in human study for GZR18 in healthy subjects

Detailed description

A double-blind, randomized, placebo-controlled, sequential, single, ascending dose study to evaluate the safety, tolerability, pharmacokinetic, and pharmacodynamic parameters of subcutaneous injections of GZR18 in healthy subjects

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DRUG	GZR-18	As previously described in Arms
OTHER	Placebo	Placebo will be dosed in an identical manner to active study drug.

Timeline

• Start date: 2022-03-08
• Primary completion: 2023-02-09
• Completion: 2023-03-09
• First posted: 2022-04-14
• Last updated: 2023-03-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study