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

NCT07189962 | Completed Phase 1

• 1 other identifier: SHR8554-106
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Moderate to Severe Postoperative Pain

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (4)

• 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.

Study Arms (2)

Normal renal function group

EXPERIMENTAL

Drug: SHR8554 Injection

Severe renal dysfunction group

EXPERIMENTAL

Drug: SHR8554 Injection

Interventions

SHR8554 Injection DRUG

SHR8554 injection.

Normal renal function group; Severe renal dysfunction group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, 266003, China

Location

Study Design

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

Study Record Dates

• First Submitted: September 17, 2025
• First Posted: September 24, 2025
• Study Start: September 20, 2022
• Primary Completion: April 13, 2023
• Study Completion: April 13, 2023
• Last Updated: September 24, 2025

Record last verified: 2025-09

Locations

CN (1)