Gan & Lee Pharmaceuticals Co., Ltd
Beijing, China
NCT Number: NCT06548997
This trial is conducted in China. The aim of the trial is to evaluate the safety and tolerability of GZR18 injection in healthy subjects following single dose and once-weekly dose for 2 consecutive weeks until reaching the target dose.
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Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Beijing, China
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
5 μg/kg-maximum tolerated dose (MTD), single dose or two doses
administered the same volume as GZR18
Time frame: after 28/35 days of treatment
Incidence of treatment-emergent adverse events (TEAE)
Time frame: 28/35 days
The peak concentration after reaching the target dose
Time frame: 28/35 days
the area under the concentration-time curve from 0 to the last time that the concentration can be accurately measured
Time frame: 28/35 days
the area under the concentration-time curve from 0 to infinity
Time frame: 28/35 days
the peak time
Time frame: 28/35 days
the elimination rate constant
Time frame: 28/35 days
the half-life
Time frame: 28/35 days
retention time
Time frame: 28/35 days
apparent clearance rate
Time frame: 28/35 days
apparent volume of distribution
Time frame: 28/35 days
extrapolation percentage of AUC0-in
Time frame: 28/35 days
average retention time
Time frame: 28/35 days
area under the concentration-time curve of fasting blood glucose from 0 to 14 hours after each administration
Time frame: 28/35 days
area under the concentration-time curve of fasting C-peptide from 0 to 14 hours after each administration
Time frame: 28/35 days
area under the concentration-time curve of fasting insulin from 0 to 14 hours after each administration
Time frame: 28/35 days
Time frame: 28/35 days
Gan and Lee Pharmaceuticals, USA
Industry
A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GZR18 Injection in Healthy Subjects Following Single Dose and Once-weekly Dose for 2 Consecutive Weeks Until Reaching the Target Dose
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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