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Clinical Trial Details

Trial ID: L3964
Source ID: NCT05292495
Associated Drug: Hr17031 Injection
Title: A Trial of HR17031 Injection With Renal Insufficiency
Acronym:
Status: UNKNOWN
Study Results: NO
Results:
Conditions: Improved Glycemic Control in Patients With Type 2 Diabetes
Interventions: DRUG: HR17031 injection
Outcome Measures: Primary: Pharmacokinetics parameters of INS068 and SHR20004: Cmax, Based on pre-dose, 2-96 hours post-dose sampling times|Pharmacokinetics parameters of INS068 and SHR20004: AUC0-t, Based on pre-dose, 2-96 hours post-dose sampling times|Pharmacokinetics parameters of INS068 and SHR20004: AUC0-inf, Based on pre-dose, 2-96 hours post-dose sampling times | Secondary: Pharmacokinetics parameters of INS068 and SHR20004: Tmax, Based on pre-dose, 2-96 hours post-dose sampling times|Pharmacokinetics parameters of INS068 and SHR20004: T1/2, Based on pre-dose, 2-96 hours post-dose sampling times|Pharmacokinetics parameters of INS068 and SHR20004: CL/F, Based on pre-dose, 2-96 hours post-dose sampling times|Pharmacokinetics parameters of INS068 and SHR20004: Vz/F, Based on pre-dose, 2-96 hours post-dose sampling times|Pharmacokinetics parameters of INS068 and SHR20004: Ae, Based on pre-dose, 2-96 hours post-dose sampling times|Pharmacokinetics parameters of INS068 and SHR20004: fe, Based on pre-dose, 2-96 hours post-dose sampling times|Pharmacokinetics parameters of INS068 and SHR20004: CLr, Based on pre-dose, 2-96 hours post-dose sampling times|Average concentrations of INS068 and SHR20004 in dialysate of ESRD, 0- 4 hours post-dose sampling times|Cumulative collection amount of INS068 and SHR20004 in dialysate of ESRD, 0- 4 hours post-dose sampling times|Dialysis clearance of INS068 and SHR20004 in dialysate of ESRD, 0- 4 hours post-dose sampling times|Binding rate of plasma protein of INS068 in serum and SHR20004 in plasma(fu), Based on pre-dose, 2-96 hours post-dose sampling times|The incidence and severity of adverse events/serious adverse events, Based on pre-dose, 2-96 hours post-dose sampling times|ADA:anti-drug antibody, Based on pre-dose、Day 5、Day14、Day 24 or early termination
Sponsor/Collaborators: Sponsor: Jiangsu HengRui Medicine Co., Ltd.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 48
Study Type: INTERVENTIONAL
Study Designs: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2022-03-31
Completion Date: 2022-12-30
Results First Posted:
Last Update Posted: 2022-03-23
Locations:
URL: https://clinicaltrials.gov/show/NCT05292495