Gan & Lee Pharmaceuticals Co., Ltd
Beijing, China
NCT Number: NCT06548945
This is a randomized, double-blind, placebo-controlled, dose-escalation phase I clinical study. A sequential design is used in this trial with a single dose escalation climb test, to investigate the safety, tolerability, and PK/PD characteristics of GZR18 injection in Chinese obese/overweight subjects.
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Notify Me18 year–65 year
All sexes
Interventional
Phase 1
Beijing, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
5 mg-maximum tolerated dose (MTD), single dose
administered the same volume as GZR18
Time frame: 50 days
Incidence of Treatment Emergent Adverse Event(s)
Time frame: 50 days
Time frame: 50 days
Maximum plasma drug concentration
Time frame: 50 days
area under the curve from 0 through the time of the last accurately measurable concentration
Time frame: 50 days
area under the curve extrapolated to infinity
Time frame: 50 days
time to maximum plasma drug concentration
Time frame: 50 days
elimination rate constant
Time frame: 50 days
half-life
Time frame: 50 days
lag time
Time frame: 50 days
apparent clearance
Time frame: 50 days
volume of distribution/F
Time frame: 50 days
percent of AUC0-inf extrapolated
Time frame: 50 days
mean residence time
Time frame: 50 days
Time frame: 50 days
Gan and Lee Pharmaceuticals, USA
Industry
A Randomized, Double-Blind, Placebo-Controlled, Dose-escalation Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics (PK/PD) of a Single Dose of GZR18 Injection in Obese/Overweight Subjects
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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