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CompletedNCT07189962Updated Sep 24, 2025

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

A Phase 1 interventional study of SHR8554 Injection in Moderate to Severe Postoperative Pain, sponsored by Jiangsu HengRui Medicine Co., Ltd.. Completed at 1 site in China. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-24.

Sponsored by Jiangsu HengRui Medicine Co., Ltd. · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 11 months after the study started (first participant enrolled Sep 2022, registered Sep 2025).
Phase
Phase 1
Study type
Interventional
Enrollment
20
Allocation
Non-randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

The study is being conducted to evaluate the safety and pharmacokinetic characteristics of SHR8554 injection in subjects with renal insufficiency and healthy subjects.

02

Conditions studied

  • Moderate to Severe Postoperative Pain
03

In context

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd. is the lead sponsor of 559 studies on the registry; 85 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 1 (11%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Normal renal function group

    Drug: SHR8554 Injection

  • Experimental
    Severe renal dysfunction group

    Drug: SHR8554 Injection

Interventions

  • DrugSHR8554 Injection

    SHR8554 injection.

06

What researchers measure

Primary outcomes

  1. Maximum observed concentration of SHR8554 (Cmax).

    Time frame: 0 hour to 48 hours after administration.

  2. Area under the serum concentration time curve (AUC) of SHR8554.

    Time frame: 0 hour to 48 hours after administration.

  3. Half-life (t1/2) of SHR8554.

    Time frame: 0 hour to 48 hours after administration.

  4. Clearance (CL) of SHR8554.

    Time frame: 0 hour to 48 hours after administration.

  5. Volume of distribution (Vz) of SHR8554.

    Time frame: 0 hour to 48 hours after administration.

Secondary outcomes

  1. Cumulative excretion (Ae) of SHR8554.

    Time frame: 0 hour to 48 hours after administration.

  2. Urinary excretion fraction (fe) of SHR8554.

    Time frame: 0 hour to 48 hours after administration.

  3. Renal clearance (CLr) of SHR8554.

    Time frame: 0 hour to 48 hours after administration.

  4. Plasma protein binding rate of SHR8554 in patients with renal insufficiency.

    Time frame: 0 hour to 48 hours after administration.

07

Study locations

1 site
  • The Affiliated Hospital of Qingdao University
    Qingdao, Shandong 266003, China
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07189962
Lead sponsor
Jiangsu HengRui Medicine Co., Ltd.
Responsible party
Sponsor
First posted
Sep 24, 2025
Start date
Sep 20, 2022
Primary completion
Apr 13, 2023
Completion
Apr 13, 2023
Last update
Sep 24, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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