Pharmacokinetics of HR17031 Injection in Healthy Subjects

Study Overview
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Brief Summary
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To compare the pharmacokinetics and safety of HR17031 injection, SHR20004 injection and/or INS068 injection in healthy subjects

Official Title
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Pharmacokinetic Study of HR17031 Injection in Healthy Subjects (Single-center, Randomized, Open-label, 4 Cycles, 4 Sequences)

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body mass index (BMI) ranges from 18 to 27 kg/m2 (both ends included), and the body weight is ≥50 kg for men and ≥45 kg for women； Fasting blood glucose during the screening is < 6.1 mmol/L； Exclusion Criteria: It has clinical significance for abnormalities Laboratory examination, if there is a clear reasonable reason, can be retested within a week, with the retest results Whether the subject meets the requirements Severe systemic disease, or a prior history of pancreatitis or other systemic problems within 1 month prior to screening; Participate in any clinical trial of a drug or medical device within 3 months prior to screening (subject to signed informed consent)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group A<br>HR17031 injection dose+INS068 injection dose+SHR20004 injection dose+(INS068+SHR20004) injection dose | Drug: HR17031 injection ；INS068 injection；SHR20004 injection<br>* HR17031 injection dose+INS068 injection dose+SHR20004 injection dose+(INS068+SHR20004) injection dose<br>|
| Experimental: Treatment group B<br>INS068 injection dose+(INS068+SHR20004)injection dose+ HR17031 injection dose +SHR20004 injection dose | Drug: HR17031 injection ；INS068 injection；SHR20004 injection<br>* INS068 injection dose+(INS068+SHR20004)injection dose+ HR17031 injection dose +SHR20004 injection dose<br>|
| Experimental: Treatment group C<br>SHR20004 injection dose+ HR17031 injection dose +(INS 068+SHR20004) injection dose+ INS068 injection dose | Drug: HR17031 injection ；INS068 injection；SHR20004 injection<br>* SHR20004 injection dose+ HR17031 injection dose +(INS 068+SHR20004) injection dose+ INS068 injection dose<br>|
| Experimental: Treatment group D<br>(INS 068+SHR20004) injection dose+ SHR20004 injection dose+ INS068 injection dose+ HR17031 injection dose | Drug: HR17031 injection ；INS068 injection；SHR20004 injection<br>* (INS 068+SHR20004) injection dose+ SHR20004 injection dose+ INS068 injection dose+ HR17031 injection dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |