Back to resultsPharmacokinetics of HR17031 Injection in Healthy Subjects
Primary Purpose
Type 2 Diabetes Mellitus
Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
HR17031 injection ；INS068 injection；SHR20004 injection
HR17031 injection ；INS068 injection；SHR20004 injection
HR17031 injection ；INS068 injection；SHR20004 injection
HR17031 injection ；INS068 injection；SHR20004 injection
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus
Eligibility Criteria
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)
Sites / Locations
- Shanghai General Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Treatment group A
Treatment group B
Treatment group C
Treatment group D
Arm Description
HR17031 injection dose+INS068 injection dose+SHR20004 injection dose+(INS068+SHR20004) injection dose
INS068 injection dose+(INS068+SHR20004)injection dose+ HR17031 injection dose +SHR20004 injection dose
SHR20004 injection dose+ HR17031 injection dose +(INS 068+SHR20004) injection dose+ INS068 injection dose
(INS 068+SHR20004) injection dose+ SHR20004 injection dose+ INS068 injection dose+ HR17031 injection dose
Outcomes
Primary Outcome Measures
Cmax：Maximum observed concentration
AUC0-t ：Area under the curve from the time of dosing time to the last measurable (positive) concentration；
AUC0-inf：Area under the curve from time 0 to infinity；
Secondary Outcome Measures
Tmax ：time of maximum observed concentration
T1/2：Half-life time ；
CL/F
Vz/F
Serum glucose within 24h after injection
C-peptide concentrations within 24h after injection
ADA：anti-drug antibody
Full Information
NCT ID
NCT05031871
First Posted
August 16, 2021
Last Updated
October 12, 2022
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05031871
Brief Title
Pharmacokinetics of HR17031 Injection in Healthy Subjects
Official Title
Pharmacokinetic Study of HR17031 Injection in Healthy Subjects (Single-center, Randomized, Open-label, 4 Cycles, 4 Sequences)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
September 2, 2021 (Actual)
Primary Completion Date
November 19, 2021 (Actual)
Study Completion Date
November 19, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu HengRui Medicine Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
To compare the pharmacokinetics and safety of HR17031 injection, SHR20004 injection and/or INS068 injection in healthy subjects
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment group A
Arm Type
Experimental
Arm Description
HR17031 injection dose+INS068 injection dose+SHR20004 injection dose+(INS068+SHR20004) injection dose
Arm Title
Treatment group B
Arm Type
Experimental
Arm Description
INS068 injection dose+(INS068+SHR20004)injection dose+ HR17031 injection dose +SHR20004 injection dose
Arm Title
Treatment group C
Arm Type
Experimental
Arm Description
SHR20004 injection dose+ HR17031 injection dose +(INS 068+SHR20004) injection dose+ INS068 injection dose
Arm Title
Treatment group D
Arm Type
Experimental
Arm Description
(INS 068+SHR20004) injection dose+ SHR20004 injection dose+ INS068 injection dose+ HR17031 injection dose
Intervention Type
Drug
Intervention Name(s)
HR17031 injection ；INS068 injection；SHR20004 injection
Intervention Description
HR17031 injection dose+INS068 injection dose+SHR20004 injection dose+(INS068+SHR20004) injection dose
Intervention Type
Drug
Intervention Name(s)
HR17031 injection ；INS068 injection；SHR20004 injection
Intervention Description
INS068 injection dose+(INS068+SHR20004)injection dose+ HR17031 injection dose +SHR20004 injection dose
Intervention Type
Drug
Intervention Name(s)
HR17031 injection ；INS068 injection；SHR20004 injection
Intervention Description
SHR20004 injection dose+ HR17031 injection dose +(INS 068+SHR20004) injection dose+ INS068 injection dose
Intervention Type
Drug
Intervention Name(s)
HR17031 injection ；INS068 injection；SHR20004 injection
Intervention Description
(INS 068+SHR20004) injection dose+ SHR20004 injection dose+ INS068 injection dose+ HR17031 injection dose
Primary Outcome Measure Information:
Title
Cmax：Maximum observed concentration
Time Frame
Day1 to Day 26
Title
AUC0-t ：Area under the curve from the time of dosing time to the last measurable (positive) concentration；
Time Frame
Day1 to Day 26
Title
AUC0-inf：Area under the curve from time 0 to infinity；
Time Frame
Day1 to Day 26
Secondary Outcome Measure Information:
Title
Tmax ：time of maximum observed concentration
Time Frame
Day1 to Day 26
Title
T1/2：Half-life time ；
Time Frame
Day1 to Day 26
Title
CL/F
Time Frame
Day1 to Day 26
Title
Vz/F
Time Frame
Day1 to Day 26
Title
Serum glucose within 24h after injection
Time Frame
Day1 to Day 23
Title
C-peptide concentrations within 24h after injection
Time Frame
Day1 to Day 23
Title
ADA：anti-drug antibody
Time Frame
Day 1、Day 8、Day15、Day 22 or early termination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Facility Information:
Facility Name
Shanghai General Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200080
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Pharmacokinetics of HR17031 Injection in Healthy Subjects
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