A Trial of HR17031 Injection With Renal Insufficiency

NCT05292495 | Unknown Phase 1

• 1 other identifier: HR17031-105
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study used a single-dose, open design to compare the pharmacokinetics of subjects with mild, moderate and severe renal insufficiency and end-stage renal disease and subjects with normal renal 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 (13)

• 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

• Pharmacokinetics parameters of INS068 and SHR20004: Ae

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

Study Arms (5)

Cohort one: mild renal insufficiency

EXPERIMENTAL

Drug: HR17031 injection

Cohort two: moderate renal insufficiency

EXPERIMENTAL

Drug: HR17031 injection

Cohort three: severe renal insufficiency

EXPERIMENTAL

Drug: HR17031 injection

Cohort four: end-stage renal disease

EXPERIMENTAL

Drug: HR17031 injection

Cohort five: normal renal function

EXPERIMENTAL

Drug: HR17031 injection

Interventions

HR17031 injection DRUG

HR17031 injection; administered subcutaneously.

Cohort five: normal renal function; Cohort four: end-stage renal disease; Cohort one: mild renal insufficiency; Cohort three: severe renal insufficiency; Cohort two: moderate renal insufficiency

Eligibility Criteria

• Age: 18 Years - 70 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.
• Age 18-70 (including threshold), male and female.
• Body mass index (BMI): 18\~30 kg/m2 (including critical value).
• Creatinine clearance (CLcr, calculated by the Cockcroft-Gault formula) must meet the following criteria:
• Subjects with mild renal insufficiency: 60-89 mL/min (including cutoffs); Subjects with moderate renal impairment: 30-59 mL/min (including cutoffs); Subjects with severe renal impairment: 15-29 mL/min (including cutoffs); Subjects with end-stage renal insufficiency: \<15 mL/min.
• The renal function status is stable, and the CLcr results of the two tests before administration (the two tests need to be separated by at least 3 days, but within 14 days) should be within ±25%. If the second result is not within ±25%, a third test can be performed (at least 3 days from the second test, but within 14 days). The third test result needs to be within ±25% of the second test result. Calculation formula: (third result - second result)/second result. The test results within 24 hours before administration will be used for the final trial grouping and subsequent PK analysis.
• Females of childbearing age must take reliable contraceptive measures and be willing to use appropriate methods of contraception during the trial and within 10 weeks after the last administration of the test drug; male subjects are willing to have no reproductive plans during the trial and within 10 weeks after the last administration of the test drug and Voluntary use of effective contraception, or surgical sterilization.
• For patients with other underlying diseases requiring drug treatment, the dose needs to be kept stable during this study.
• 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.
• Able to complete the research in accordance with the requirements of the experimental protocol.
• Age 18-70 (including threshold), male and female.
• Body mass index (BMI): 18\~30 kg/m2 (including critical value).
• Creatinine clearance rate (CLcr, calculated by Cockcroft-Gault formula) ≥ 90mL/min.
• The renal function status is stable, and the CLcr results of the two tests before administration (the two tests need to be separated by at least 3 days, but within 14 days) should be within ±25%. Calculation formula: (second result - first result)/first result. The test results within 24 hours before administration will be used for the final trial grouping and subsequent PK analysis.
• Females of childbearing age must take reliable contraceptive measures and be willing to use appropriate methods of contraception during the trial and within 10 weeks after the last administration of the test drug; male subjects are willing to have no reproductive plans during the trial and within 10 weeks after the last administration of the test drug and Voluntary use of effective contraception, or surgical sterilization.

You may not qualify if:

• Have done kidney transplantation.
• Renal dialysis is required during the study.
• Those with allergic constitution, including those with a history of severe drug allergy or drug allergy, or known or suspected to be allergic to any component in the study drug.
• Urinary incontinence or anuria (eg \<100ml/d).
• Those who have a history of drug and/or alcohol abuse, who are positive for alcohol and drug screening, or who have a history of drug abuse in the past five years or who have used drugs in the 3 months before the test; and who cannot smoke or abstain from alcohol during the test.
• Pregnant or lactating women, or those with a positive blood pregnancy result.
• Those who donated blood or participated in any clinical trial drugs within 3 months before screening.
• Those who have taken other prescription drugs, over-the-counter drugs, Chinese herbal medicines or food supplements other than those used to treat renal insufficiency and other concomitant diseases within 14 days before administration.
• Combined with other viral infections (anti-HCV, anti-HIV positive, HBsAg positive or combined with positive syphilis serology).
• Major surgery or surgical incision was not fully healed within 6 months before screening.
• History or clinical symptoms of deep vein thrombosis or other thromboembolic events suggest thrombophilia.
• Active heart disease within 6 months before the first administration of the study drug, including: severe/unstable angina pectoris, myocardial infarction, symptomatic congestive heart failure and ventricular arrhythmia requiring drug treatment.
• Have a history of epilepsy, or a disease that can induce epileptic seizures within 12 months before the first administration of the study drug (including a history of transient ischemic attack, cerebral apoplexy (except for cerebral ischemic lesions found by simple imaging examination), Brain trauma with disturbance of consciousness requires hospitalization).
• Malignant tumors, or a history of malignant tumors within 5 years before screening (except for skin non-melanoma that has been treated and has no signs of recurrence, and excised cervical intraepithelial neoplasia).
• In addition to renal insufficiency and other concomitant diseases, the researcher makes judgments based on medical history inquiry, comprehensive physical examination, routine laboratory tests (blood routine, blood biochemistry, urine routine, etc.), X-chest X-ray, abdominal B-ultrasound, etc. Abnormal clinical significance.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Central Study Contacts

Sheng Feng, Ph.D.

CONTACT

+86-0518-82342973; Sheng.feng@hengrui.com

Yifan Li

CONTACT

+86-0518-82342973; yifan.li@hengrui.com

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, moderate, severe renal insufficiency and end-stage renal disease and subjects with normal renal function.

Study Record Dates

• First Submitted: March 15, 2022
• First Posted: March 23, 2022
• Study Start: March 31, 2022
• Primary Completion: December 15, 2022
• Study Completion: December 30, 2022
• Last Updated: March 23, 2022

Record last verified: 2022-03