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Clinical Trial Details

Trial ID: L6960
Source ID: NCT06548997
Associated Drug: Gzr18
Title: A Phase I Study of GZR18 Injection in Healthy Subjects
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes|Overweight and Obesity
Interventions: DRUG: GZR18|OTHER: Placebo
Outcome Measures: Primary: TEAE, Incidence of treatment-emergent adverse events (TEAE), after 28/35 days of treatment | Secondary: Cmax, The peak concentration after reaching the target dose, 28/35 days|AUClast, the area under the concentration-time curve from 0 to the last time that the concentration can be accurately measured, 28/35 days|AUC0-inf, the area under the concentration-time curve from 0 to infinity, 28/35 days|Tmax, the peak time, 28/35 days|λz, the elimination rate constant, 28/35 days|t1/2, the half-life, 28/35 days|tlag, retention time, 28/35 days|CL/F, apparent clearance rate, 28/35 days|Vz/F, apparent volume of distribution, 28/35 days|AUC%extra, extrapolation percentage of AUC0-in, 28/35 days|MRT, average retention time, 28/35 days|AUCglucose0-14h, area under the concentration-time curve of fasting blood glucose from 0 to 14 hours after each administration, 28/35 days|AUCc-peptide0-14h, area under the concentration-time curve of fasting C-peptide from 0 to 14 hours after each administration, 28/35 days|AUCinsulin0-14h, area under the concentration-time curve of fasting insulin from 0 to 14 hours after each administration, 28/35 days|body weight, 28/35 days|body mass index (BMI), 28/35 days
Sponsor/Collaborators: Sponsor: Gan and Lee Pharmaceuticals, USA
Gender: ALL
Age: ADULT
Phases: PHASE1
Enrollment: 57
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2021-12-02
Completion Date: 2022-10-20
Results First Posted:
Last Update Posted: 2024-08-14
Locations: Gan & Lee Pharmaceuticals Co., Ltd, Beijing, China
URL: https://clinicaltrials.gov/show/NCT06548997