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Clinical Trial Details

Trial ID: L6743
Source ID: NCT05151705
Associated Drug: Hr17031 Injection
Title: A Trial of HR17031 Injection With Hepatic Insufficiency
Acronym:
Status: UNKNOWN
Study Results: NO
Results:
Conditions: Improved Glycemic Control in Patients With Type 2 Diabetes
Interventions: DRUG: HR17031 injection|DRUG: HR17031 injection|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|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|Pharmacodynamic:Serum c-peptide, Based on pre-dose, 8-24 hours post-dose sampling times
Sponsor/Collaborators: Sponsor: Jiangsu HengRui Medicine Co., Ltd.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 24
Study Type: INTERVENTIONAL
Study Designs: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2021-12-20
Completion Date: 2022-06-30
Results First Posted:
Last Update Posted: 2021-12-09
Locations:
URL: https://clinicaltrials.gov/show/NCT05151705