Status:
COMPLETED
A Pharmacokinetic Study of SHR8554 Injection in the Population With Renal Insufficiency and Healthy Participants
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Moderate to Severe Postoperative Pain
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
The study is being conducted to evaluate the safety and pharmacokinetic characteristics of SHR8554 injection in subjects with renal insufficiency and healthy subjects.
Eligibility Criteria
Inclusion
- Able and willing to provide a written informed consent;
- The estimated glomerular filtration rate (eGFR) of subjects in groups must meet the corresponding standards;
- Male or female;
- with a body mass index (BMI) between 18.0 and 28.0 kg/m2.
Exclusion
- History of clinically significant allergies, known allergy to SHR8554, or any other structural analogs;
- Subjects with positive tests for infectious diseases;
- Pregnancy or lactation women, or a fertility male or female is not willing to contraception during test;
- Unable to tolerate venipunctures or have a history of fainting needles and blood;
- Historic abuse of alcoholic beverages;
- Smoke ≥ 10 cigarettes per day within 3 months prior to the study;
- History of drug abuse;
- Diseases with abnormal clinical manifestations that occurred before screening or are currently occurring and need to be excluded for normal renal function group;
- Vital signs, physical examination, 12-lead electrocardiogram, or laboratory examination deemed clinically significant by the investigator for normal renal function group;
- History of renal transplantation and/or requirement for renal dialysis treatment during the study period for severe renal function group;
- Urinary incontinence or anuria (e.g., \< 100 mL/day) for severe renal function group;
- Other reasons that the investigator consider it inappropriate to participate in the trial.
Key Trial Info
Start Date :
September 20 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 13 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT07189962
Start Date
September 20 2022
End Date
April 13 2023
Last Update
September 24 2025
Active Locations (1)
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1
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China, 266003