Pharmacokinetics of HR17031 Injection in Healthy Subjects

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05031871
• Other study ID #: HR17031-102
• Status: Completed
• Phase: Phase 1
• Start date: September 2, 2021
• Est. completion date: November 19, 2021

Study information

• Verified date: October 2022
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: November 19, 2021
• Est. primary completion date: November 19, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• HR17031 injection ;INS068 injection;SHR20004 injection
HR17031 injection dose+INS068 injection dose+SHR20004 injection dose+(INS068+SHR20004) injection dose
• HR17031 injection ;INS068 injection;SHR20004 injection
INS068 injection dose+(INS068+SHR20004)injection dose+ HR17031 injection dose +SHR20004 injection dose
• HR17031 injection ;INS068 injection;SHR20004 injection
SHR20004 injection dose+ HR17031 injection dose +(INS 068+SHR20004) injection dose+ INS068 injection dose
• HR17031 injection ;INS068 injection;SHR20004 injection
(INS 068+SHR20004) injection dose+ SHR20004 injection dose+ INS068 injection dose+ HR17031 injection dose

Locations

Country	Name	City	State
China	Shanghai General Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax:Maximum observed concentration		Day1 to Day 26
Primary	AUC0-t :Area under the curve from the time of dosing time to the last measurable (positive) concentration;		Day1 to Day 26
Primary	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
Secondary	T1/2:Half-life time ;		Day1 to Day 26
Secondary	CL/F		Day1 to Day 26
Secondary	Vz/F		Day1 to Day 26
Secondary	Serum glucose within 24h after injection		Day1 to Day 23
Secondary	C-peptide concentrations within 24h after injection		Day1 to Day 23
Secondary	ADA:anti-drug antibody		Day 1?Day 8?Day15?Day 22 or early termination