Pharmacokinetics of HR17031 Injection in Healthy Subjects

Phase 1

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: HR17031 injection ；INS068 injection；SHR20004 injection

• Registration Number: NCT05031871
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-08-16
• Study First Submitted QC: 2021-08-31
• Study Start: 2021-09-02
• Study First Posted: 2021-09-02
• Primary Completion: 2021-11-19
• Study Completion: 2021-11-19
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-12
• Last Update Posted: 2022-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

1. 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；
2. Fasting blood glucose during the screening is < 6.1 mmol/L；

Exclusion Criteria

1. 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
2. Severe systemic disease, or a prior history of pancreatitis or other systemic problems within 1 month prior to screening;
3. Participate in any clinical trial of a drug or medical device within 3 months prior to screening (subject to signed informed consent)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment group A	HR17031 injection ；INS068 injection；SHR20004 injection	HR17031 injection dose+INS068 injection dose+SHR20004 injection dose+(INS068+SHR20004) injection dose
Treatment group B	HR17031 injection ；INS068 injection；SHR20004 injection	INS068 injection dose+(INS068+SHR20004)injection dose+ HR17031 injection dose +SHR20004 injection dose
Treatment group C	HR17031 injection ；INS068 injection；SHR20004 injection	SHR20004 injection dose+ HR17031 injection dose +(INS 068+SHR20004) injection dose+ INS068 injection dose
Treatment group D	HR17031 injection ；INS068 injection；SHR20004 injection	(INS 068+SHR20004) injection dose+ SHR20004 injection dose+ INS068 injection dose+ HR17031 injection dose

Primary Outcome Measures

Name	Time	Method
AUC0-inf：Area under the curve from time 0 to infinity；	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
Cmax：Maximum observed concentration	Day1 to Day 26

Secondary Outcome Measures

Name	Time	Method
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
ADA：anti-drug antibody	Day 1、Day 8、Day15、Day 22 or early termination
C-peptide concentrations within 24h after injection	Day1 to Day 23

Trial Locations

Locations (1)

Shanghai General Hospital; 🇨🇳 Shanghai, Shanghai, China