A Multi-center, Single-dose, Open-label, Parallel Design, Pharmacokinetics Study of HRS9531injection in Healthy Subjects and Subjects With Impaired Renal Function

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

The purpose of this study is to assess how fast HRS9531 gets into the blood stream and how long it takes the body to remove it in participants with impaired kidney function compared to healthy participants.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: t
View:

• Ability to understand the trial procedures and possible adverse events, be able and willing to provide a written informed consent;

• Age 18-65 years on the date of signing informed consent (inclusive);

• Body mass index (BMI) within the range of 19.0-40.0 kg/m2 (inclusive);

• Renal function, assessed by estimated glomerular filtration rate at screening (eGFR):

‣ Normal renal function: 90-129 mL/min (inclusive);

⁃ Mild impairment: 60-89 mL/min (inclusive);

⁃ Moderate impairment: 30-59 mL/min (inclusive);

⁃ Severe impairment: 15-29 mL/min (inclusive);

• Females of childbearing potential should have negative baseline blood pregnancy test, and must use highly effective contraception from signing the informed consent form to 2 months after the last dose of trial drug; Male subjects must agree to either remain abstinent or use highly effective contraceptive measures during the trial and 2 months after last dose of the trial drug, or have been surgically sterilized;

• Stable renal function, assessed by two eGFR during screening (apart at least 3 days);

• Diagnosed as stable, chronic renal disease for at least 3 months.

Locations
Other Locations
China
Chengdu Xinhua Hospital
RECRUITING
Chengdu
Contact Information
Primary
SICHEN WANG
sichen.wang.sw104@hengrui.com
+86-0518-82342973
Backup
YANYAN ZHANG
yanyan.zhang@hengrui.com
+86-0518-82342973
Time Frame
Start Date: 2024-02-28
Estimated Completion Date: 2024-07-31
Participants
Target number of participants: 32
Treatments
Experimental: A group (Healthy Control)
Experimental: B group (Mild Renal Impairment)
Experimental: C group (Moderate Renal Impairment)
Experimental: D group (Severe Renal Impairment)
Related Therapeutic Areas
Sponsors
Leads: Fujian Shengdi Pharmaceutical Co., Ltd.

This content was sourced from clinicaltrials.gov

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