Pharmacokinetics of HR17031 Injection in Healthy Subjects

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

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

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200080
      • Shanghai General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): September 2, 2021
• Primary Completion (Actual): November 19, 2021
• Study Completion (Actual): November 19, 2021

Study Registration Dates

• First Submitted: August 16, 2021
• First Submitted That Met QC Criteria: August 31, 2021
• First Posted (Actual): September 2, 2021

Study Record Updates

• Last Update Posted (Actual): October 13, 2022
• Last Update Submitted That Met QC Criteria: October 12, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: HR17031-102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No