A Trial of HR17031 Injection With Hepatic Insufficiency

NCT05151705 | Unknown Phase 1

• 1 other identifier: HR17031-103
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Improved Glycemic Control in Patients With Type 2 Diabetes

Outcome Measures

Primary Outcomes (3)

• Pharmacokinetics parameters of INS068 and SHR20004: Cmax

  Based on pre-dose, 2-96 hours post-dose sampling times

• Pharmacokinetics parameters of INS068 and SHR20004: AUC0-t

  Based on pre-dose, 2-96 hours post-dose sampling times

• Pharmacokinetics parameters of INS068 and SHR20004: AUC0-inf

  Based on pre-dose, 2-96 hours post-dose sampling times

Secondary Outcomes (7)

• Pharmacokinetics parameters of INS068 and SHR20004: Tmax

  Based on pre-dose, 2-96 hours post-dose sampling times

• Pharmacokinetics parameters of INS068 and SHR20004: T1/2

  Based on pre-dose, 2-96 hours post-dose sampling times

• Pharmacokinetics parameters of INS068 and SHR20004: CL/F

  Based on pre-dose, 2-96 hours post-dose sampling times

• Pharmacokinetics parameters of INS068 and SHR20004: Vz/F

  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)

  Based on pre-dose, 2-96 hours post-dose sampling times

Study Arms (3)

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

Interventions

HR17031 injection DRUG

Treatment group A:HR17031 injection; 10U/0.024mg

Treatment group A: HR17031 injection

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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;
• 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);

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Central Study Contacts

Sheng Feng, Ph.D.

CONTACT

13817253036; Sheng.feng@hengrui.com

Yuxiong Gao, Ph.D.

CONTACT

19821262236; gaoyu.xiong@hengrui.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Compare the pharmacokinetics of HR17031 injection in subjects with mild and moderate liver impairment and normal liver function

Study Record Dates

• First Submitted: December 7, 2021
• First Posted: December 9, 2021
• Study Start: December 20, 2021
• Primary Completion: June 15, 2022
• Study Completion: June 30, 2022
• Last Updated: December 9, 2021

Record last verified: 2021-12