A Pharmacokinetic Study of SHR8554 Injection in the Population With Renal Insufficiency and Healthy Participants

Not Applicable

Completed

• Conditions: Moderate to Severe Postoperative Pain
• Interventions: Drug: SHR8554 Injection

• Registration Number: NCT07189962
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-20
• Primary Completion: 2023-04-13
• Study Completion: 2023-04-13
• Status Verified: 2025-09
• Study First Submitted: 2025-09-17
• Study First Submitted QC: 2025-09-17
• Last Update Submitted: 2025-09-17
• Study First Posted: 2025-09-24
• Last Update Posted: 2025-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Able and willing to provide a written informed consent;
2. The estimated glomerular filtration rate (eGFR) of subjects in groups must meet the corresponding standards;
3. Male or female;
4. with a body mass index (BMI) between 18.0 and 28.0 kg/m2.

Exclusion Criteria

1. History of clinically significant allergies, known allergy to SHR8554, or any other structural analogs;
2. Subjects with positive tests for infectious diseases;
3. Pregnancy or lactation women, or a fertility male or female is not willing to contraception during test;
4. Unable to tolerate venipunctures or have a history of fainting needles and blood;
5. Historic abuse of alcoholic beverages;
6. Smoke ≥ 10 cigarettes per day within 3 months prior to the study;
7. History of drug abuse;
8. Diseases with abnormal clinical manifestations that occurred before screening or are currently occurring and need to be excluded for normal renal function group;
9. Vital signs, physical examination, 12-lead electrocardiogram, or laboratory examination deemed clinically significant by the investigator for normal renal function group;
10. History of renal transplantation and/or requirement for renal dialysis treatment during the study period for severe renal function group;
11. Urinary incontinence or anuria (e.g., < 100 mL/day) for severe renal function group;
12. Other reasons that the investigator consider it inappropriate to participate in the trial.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal renal function group	SHR8554 Injection	-
Severe renal dysfunction group	SHR8554 Injection	-

Primary Outcome Measures

Name	Time	Method
Maximum observed concentration of SHR8554 (Cmax).	0 hour to 48 hours after administration.
Area under the serum concentration time curve (AUC) of SHR8554.	0 hour to 48 hours after administration.
Half-life (t1/2) of SHR8554.	0 hour to 48 hours after administration.
Clearance (CL) of SHR8554.	0 hour to 48 hours after administration.
Volume of distribution (Vz) of SHR8554.	0 hour to 48 hours after administration.

Secondary Outcome Measures

Name	Time	Method
Cumulative excretion (Ae) of SHR8554.	0 hour to 48 hours after administration.
Urinary excretion fraction (fe) of SHR8554.	0 hour to 48 hours after administration.
Renal clearance (CLr) of SHR8554.	0 hour to 48 hours after administration.
Plasma protein binding rate of SHR8554 in patients with renal insufficiency.	0 hour to 48 hours after administration.

Trial Locations

Locations (1)

The Affiliated Hospital of Qingdao University; 🇨🇳 Qingdao, Shandong, China