| Trial ID: | L6591 |
| Source ID: | NCT05031871
|
| Associated Drug: |
Hr17031 Injection ；Ins068 Injection；Shr20004 Injection
|
| Title: |
Pharmacokinetics of HR17031 Injection in Healthy Subjects
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: HR17031 injection ；INS068 injection；SHR20004 injection|DRUG: HR17031 injection ；INS068 injection；SHR20004 injection|DRUG: HR17031 injection ；INS068 injection；SHR20004 injection|DRUG: HR17031 injection ；INS068 injection；SHR20004 injection
|
| Outcome Measures: |
Primary: Cmax：Maximum observed concentration, Day1 to Day 26|AUC0-t ：Area under the curve from the time of dosing time to the last measurable (positive) concentration；, Day1 to Day 26|AUC0-inf：Area under the curve from time 0 to infinity；, Day1 to Day 26 | Secondary: Tmax ：time of maximum observed concentration, Day1 to Day 26|T1/2：Half-life time ；, Day1 to Day 26|CL/F, Day1 to Day 26|Vz/F, Day1 to Day 26|Serum glucose within 24h after injection, Day1 to Day 23|C-peptide concentrations within 24h after injection, Day1 to Day 23|ADA：anti-drug antibody, Day 1、Day 8、Day15、Day 22 or early termination
|
| Sponsor/Collaborators: |
Sponsor: Jiangsu HengRui Medicine Co., Ltd.
|
| Gender: |
ALL
|
| Age: |
ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
24
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2021-09-02
|
| Completion Date: |
2021-11-19
|
| Results First Posted: |
|
| Last Update Posted: |
2022-10-13
|
| Locations: |
Shanghai General Hospital, Shanghai, Shanghai, 200080, China
|
| URL: |
https://clinicaltrials.gov/show/NCT05031871
|
