Improved Glycemic Control in Patients With Type 2 DiabetesPhase 1NCT05151705
A Trial of HR17031 Injection With Hepatic Insufficiency
A Phase 1 study testing HR17031 injection in people with Improved Glycemic Control in Patients With Type 2 Diabetes, run by Jiangsu HengRui Medicine Co., Ltd..
Trial summary
This study used a single-dose, open design to compare the pharmacokinetics of subjects with mild and moderate liver impairment and subjects with normal liver function. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Improved Glycemic Control in Patients With Type 2 Diabetes
- What is being tested?
- HR17031 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 20 Dec 2021to 30 Jun 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Signed the informed consent before the test, and fully understood the test content, process and possible adverse reactions; And able to complete the research according to the requirements of the test protocol;
- Subject (including partner) is willing to voluntarily take effective contraceptive measures within 10 weeks from screening to the last study drug administration. For specific contraceptive measures, see Appendix 1;
- Age 18-65 (including threshold), male and female;
- The weight of male subjects should not be less than 50 kg, and that of female subjects should not be less than 45 kg. Body mass index (BMI) : 18~32 kg/m2 (including critical value);
- For subjects with normal liver function, normal or abnormal clinical laboratory tests (blood routine, blood biochemistry, urine routine, coagulation function) have no clinical significance;
- Subjects with normal liver function: no previous serious primary diseases of important organs, including but not limited to gastrointestinal, respiratory, kidney, liver, nervous, blood, endocrine, tumor, immune, mental or cardiovascular diseases.
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- For subjects with impaired liver function, the following inclusion criteria should also be met:
- Those who have not taken medication within 4 weeks prior to screening, or who require long-term treatment for liver damage and/or other comorbidities, have taken stable medication for at least 4 weeks;
- Patients with child-Pugh grade A or B hepatic dysfunction resulting from previous primary liver disease.
Who cannot join
- Allergic disposition, or known or suspected allergy to any of the ingredients in the study drug;
- Smoked more than 5 cigarettes per day on average within 3 months before screening;
- Average daily alcohol intake in the 3 months prior to screening exceeds the following criteria: 15g (e.g., 145 mL wine, 497 mL beer or 43 mL low-alcohol liquor) for women and 25g (e.g., 290 mL wine, 994 mL beer or 86mL low-alcohol liquor) for men;
- A history of drug abuse within 3 months prior to the screening period;
- Those who donated blood or lost blood ≥400 mL or received blood transfusion within 3 months prior to screening;
- Major surgery or surgical incision not completely healed within 6 months prior to screening;
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- Taking Chinese herbal medicine within 2 weeks before administration;
- Have a malignant tumor, or have a history of malignant tumor in the 5 years prior to screening (excluding treated skin non-melanoma with no signs of recurrence, and excised cervical intraepithelial neoplasia);
- Systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg at screening time;
- Female subjects are lactating or have positive serum pregnancy results during the screening period or during the test;
- For subjects with normal liver function: participants in clinical trials of any drug or medical device within 3 months prior to screening; For subjects with impaired liver function: participants in clinical trials of any drug or medical device within 1 month prior to screening;
- Patients whose ECG abnormality is clinically significant (e.g., tachycardia/bradycardia requiring medical treatment, degree II-III ATrioventricular block, or prolonged QTcF interval (males ≥470 ms, females ≥480 ms) (corrected according to Fridericia's formula) and determined by clinicians to be unsuitable for this study;
- Creatinine clearance (CLcr, calculated by Cockcroft-Gault formula, Appendix III) ≤60 mL/min;
- Subjects with normal liver function: those who are positive for hepatitis B surface antigen, hepatitis C antibody or hepatitis C core antigen, HIV antibody or syphilis antibody screened are excluded;
- Screening for positive urine drugs (morphine, cannabis);
- Within 1 day before administration, those who have eaten any food or drink containing alcohol (or positive breath test for alcohol), grapefruit juice/grapefruit juice, methylxanthine (such as coffee, tea, cola, chocolate, energy drink), strenuous exercise or other factors affecting drug absorption, distribution, metabolism, excretion, etc.;
- Patients who are expected to be prone to surgery or hospitalization during the study period;
- Any factors that the investigator considers inappropriate for participation in this study.
- Supplementary exclusion criteria for subjects with liver function impairment (exclusion if meeting 1 of these criteria) :
- History of liver transplantation;
- Subjects with liver failure or cirrhosis with hepatic encephalopathy, hepatocellular carcinoma, esophageal and gastric variceal hemorrhage and other complications deemed unsuitable for the study by the investigator;
- In addition to the primary liver disease itself, has a history of any serious illness, or history of researchers think that may affect the test results and/or anomalies have clinical significance of clinical laboratory tests, including but not limited to the circulatory system, endocrine system, nervous system, digestive system, urinary system, or blood, immune, spirit and metabolic disease.
- HIV antibody screening positive; If syphilis antibody is positive, rapid plasma rereaction test (RPR) should be added. If RPR is positive at the same time, it should be excluded.
- Alpha-fetoprotein > 50 ng/mL; Or neutrophil count (ANC) ≥0.75×109/L (1,500/mm3); Or Hgb ≤7.0 g/dL (90 g/L); Or ALT and AST ≥10 times the upper limit of normal (ULN) were excluded.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Pharmacokinetics and Safety of HR17031 Injection in Subjects With Mild and Moderate Liver Impairment and Normal Liver Function.
This study used a single-dose, open design to compare the pharmacokinetics of subjects with mild and moderate liver impairment and subjects with normal liver function.
- Being tested
- HR17031 injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HR17031 injectionDrug
Treatment group A:HR17031 injection; 10U/0.024mg
HR17031 injectionDrug
Treatment group B: HR17031 injection; 10U/0.024mg
HR17031 injectionDrug
Treatment group C: HR17031 injection; 10U/0.024mg
| Study group | Role | What they receive |
|---|---|---|
| Treatment group A: HR17031 injection | Experimental | Not described Receives: Drug: HR17031 injection |
| Treatment group B: HR17031 injection | Experimental | Not described Receives: Drug: HR17031 injection |
| Treatment group C: HR17031 injection | Experimental | Not described Receives: Drug: HR17031 injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics parameters of INS068 and SHR20004: Cmax
Measured: Based on pre-dose, 2-96 hours post-dose sampling times
Pharmacokinetics parameters of INS068 and SHR20004: AUC0-t
Measured: Based on pre-dose, 2-96 hours post-dose sampling times
Pharmacokinetics parameters of INS068 and SHR20004: AUC0-inf
Measured: Based on pre-dose, 2-96 hours post-dose sampling times
Secondary outcomes (7)
Pharmacokinetics parameters of INS068 and SHR20004: Tmax
Measured: Based on pre-dose, 2-96 hours post-dose sampling times
Pharmacokinetics parameters of INS068 and SHR20004: T1/2
Measured: Based on pre-dose, 2-96 hours post-dose sampling times
Pharmacokinetics parameters of INS068 and SHR20004: CL/F
Measured: Based on pre-dose, 2-96 hours post-dose sampling times
Pharmacokinetics parameters of INS068 and SHR20004: Vz/F
Measured: Based on pre-dose, 2-96 hours post-dose sampling times
Binding rate of plasma protein of INS068 in serum and SHR20004 in plasma(fu)
Measured: Based on pre-dose, 2-96 hours post-dose sampling times
The incidence and severity of adverse events/serious adverse events
Measured: Based on pre-dose, 2-96 hours post-dose sampling times
Pharmacodynamic：Serum c-peptide
Measured: Based on pre-dose, 8-24 hours post-dose sampling times
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2021
- Study start20 Dec 2021 (estimated)
- Primary completion15 Jun 2022 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Improved Glycemic Control in Patients With Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Compare the pharmacokinetics of HR17031 injection in subjects with mild and moderate liver impairment and normal liver function
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05151705
- Sponsor's protocol ID
- HR17031-103
- Status last verified
- Dec 2021
- First submitted
- 7 Dec 2021
- Last updated
- 9 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics and Safety of HR17031 Injection in Subjects With Mild and Moderate Liver Impairment and Normal Liver Function.
- ClinicalTrials.gov ID
- NCT05151705
- Acronym / sponsor ID
- HR17031-103
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Dec 2021 (estimated)
- Primary completion
- 15 Jun 2022 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 9 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study used a single-dose, open design to compare the pharmacokinetics of subjects with mild and moderate liver impairment and subjects with normal liver function.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Compare the pharmacokinetics of HR17031 injection in subjects with mild and moderate liver impairment and normal liver function
| Arm | Type | Receives |
|---|---|---|
| Treatment group A: HR17031 injection | Experimental | Drug: HR17031 injection |
| Treatment group B: HR17031 injection | Experimental | Drug: HR17031 injection |
| Treatment group C: HR17031 injection | Experimental | Drug: HR17031 injection |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Signed the informed consent before the test, and fully understood the test content, process and possible adverse reactions; And able to complete the research according to the requirements of the test protocol;
- Subject (including partner) is willing to voluntarily take effective contraceptive measures within 10 weeks from screening to the last study drug administration. For specific contraceptive measures, see Appendix 1;
- Age 18-65 (including threshold), male and female;
- The weight of male subjects should not be less than 50 kg, and that of female subjects should not be less than 45 kg. Body mass index (BMI) : 18~32 kg/m2 (including critical value);
- For subjects with normal liver function, normal or abnormal clinical laboratory tests (blood routine, blood biochemistry, urine routine, coagulation function) have no clinical significance;
Key exclusion criteria (24 listed)
- Allergic disposition, or known or suspected allergy to any of the ingredients in the study drug;
- Smoked more than 5 cigarettes per day on average within 3 months before screening;
- Average daily alcohol intake in the 3 months prior to screening exceeds the following criteria: 15g (e.g., 145 mL wine, 497 mL beer or 43 mL low-alcohol liquor) for women and 25g (e.g., 290 mL wine, 994 mL beer or 86mL low-alcohol liquor) for men;
- A history of drug abuse within 3 months prior to the screening period;
- Those who donated blood or lost blood ≥400 mL or received blood transfusion within 3 months prior to screening;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HR17031 injectionTreatment group A:HR17031 injection; 10U/0.024mg | Drug | Treatment group A: HR17031 injection |
| HR17031 injectionTreatment group B: HR17031 injection; 10U/0.024mg | Drug | Treatment group B: HR17031 injection |
| HR17031 injectionTreatment group C: HR17031 injection; 10U/0.024mg | Drug | Treatment group C: HR17031 injection |
Primary outcome
Pharmacokinetics parameters of INS068 and SHR20004: Cmax
Time frame: Based on pre-dose, 2-96 hours post-dose sampling times
Pharmacokinetics parameters of INS068 and SHR20004: AUC0-t
Time frame: Based on pre-dose, 2-96 hours post-dose sampling times
Pharmacokinetics parameters of INS068 and SHR20004: AUC0-inf
Time frame: Based on pre-dose, 2-96 hours post-dose sampling times
7 secondary outcomes
Pharmacokinetics parameters of INS068 and SHR20004: Tmax
Time frame: Based on pre-dose, 2-96 hours post-dose sampling times
Pharmacokinetics parameters of INS068 and SHR20004: T1/2
Time frame: Based on pre-dose, 2-96 hours post-dose sampling times
Pharmacokinetics parameters of INS068 and SHR20004: CL/F
Time frame: Based on pre-dose, 2-96 hours post-dose sampling times
Pharmacokinetics parameters of INS068 and SHR20004: Vz/F
Time frame: Based on pre-dose, 2-96 hours post-dose sampling times
Binding rate of plasma protein of INS068 in serum and SHR20004 in plasma(fu)
Time frame: Based on pre-dose, 2-96 hours post-dose sampling times
The incidence and severity of adverse events/serious adverse events
Time frame: Based on pre-dose, 2-96 hours post-dose sampling times
Pharmacodynamic：Serum c-peptide
Time frame: Based on pre-dose, 8-24 hours post-dose sampling times
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2021.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HR17031 injection in people with Improved Glycemic Control in Patients With Type 2 Diabetes, run by Jiangsu HengRui Medicine Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sheng Feng, Ph.D. (13817253036, Sheng.feng@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics parameters of INS068 and SHR20004: Cmax (time frame: Based on pre-dose, 2-96 hours post-dose sampling times). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2021; AzTrials last refreshed its copy on 8 Nov 2026.