Pharmacokinetics of HR17031 Injection in Healthy Subjects

Hengrui Medicine

Status and phase: Completed; Phase 1

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: HR17031 injection ；INS068 injection；SHR20004 injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT05031871

HR17031-102

Details and patient eligibility

About

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

Enrollment: 24 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 4 patient groups

Treatment group A

Experimental group

Description:

HR17031 injection dose+INS068 injection dose+SHR20004 injection dose+(INS068+SHR20004) injection dose

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

Treatment group B

Experimental group

Description:

INS068 injection dose+(INS068+SHR20004)injection dose+ HR17031 injection dose +SHR20004 injection dose

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

Treatment group C

Experimental group

Description:

SHR20004 injection dose+ HR17031 injection dose +(INS 068+SHR20004) injection dose+ INS068 injection dose

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

Treatment group D

Experimental group

Description:

(INS 068+SHR20004) injection dose+ SHR20004 injection dose+ INS068 injection dose+ HR17031 injection dose

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