Pharmacokinetics of HR17031 Injection in Healthy Subjects

NCT ID: NCT05031871

Last Updated: 2022-10-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-02

Study Completion Date

2021-11-19

Brief Summary

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

Detailed Description

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Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment group A

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

Group Type EXPERIMENTAL

HR17031 injection ;INS068 injection;SHR20004 injection

Intervention Type DRUG

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

Treatment group B

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

Group Type EXPERIMENTAL

HR17031 injection ;INS068 injection;SHR20004 injection

Intervention Type DRUG

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

Treatment group C

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

Group Type EXPERIMENTAL

HR17031 injection ;INS068 injection;SHR20004 injection

Intervention Type DRUG

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

Treatment group D

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

Group Type EXPERIMENTAL

HR17031 injection ;INS068 injection;SHR20004 injection

Intervention Type DRUG

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

Interventions

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HR17031 injection ;INS068 injection;SHR20004 injection

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

Intervention Type DRUG

HR17031 injection ;INS068 injection;SHR20004 injection

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

Intervention Type DRUG

HR17031 injection ;INS068 injection;SHR20004 injection

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

Intervention Type DRUG

HR17031 injection ;INS068 injection;SHR20004 injection

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

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Shanghai General Hospital

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Other Identifiers

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HR17031-102

Identifier Type: -

Identifier Source: org_study_id

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