Moderate to Severe Postoperative PainPhase 1NCT07189962
A Pharmacokinetic Study of SHR8554 Injection in the Population With Renal Insufficiency and Healthy Participants
A Phase 1 study testing SHR8554 Injection in people with Moderate to Severe Postoperative Pain, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
The study is being conducted to evaluate the safety and pharmacokinetic characteristics of SHR8554 injection in subjects with renal insufficiency and healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Moderate to Severe Postoperative Pain
- What is being tested?
- SHR8554 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 20 Sep 2022to 13 Apr 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266003
About this study
Official title: A Pharmacokinetic Study of SHR8554 Injection in Chinese Patients With Renal Insufficiency and Healthy Subjects
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
- Being tested
- SHR8554 Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR8554 InjectionDrug
SHR8554 injection.
| Study group | Role | What they receive |
|---|---|---|
| Normal renal function group | Experimental | Not described Receives: Drug: SHR8554 Injection |
| Severe renal dysfunction group | Experimental | Not described Receives: Drug: SHR8554 Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed concentration of SHR8554 (Cmax).
Measured: 0 hour to 48 hours after administration.
Area under the serum concentration time curve (AUC) of SHR8554.
Measured: 0 hour to 48 hours after administration.
Half-life (t1/2) of SHR8554.
Measured: 0 hour to 48 hours after administration.
Clearance (CL) of SHR8554.
Measured: 0 hour to 48 hours after administration.
Volume of distribution (Vz) of SHR8554.
Measured: 0 hour to 48 hours after administration.
Secondary outcomes (4)
Cumulative excretion (Ae) of SHR8554.
Measured: 0 hour to 48 hours after administration.
Urinary excretion fraction (fe) of SHR8554.
Measured: 0 hour to 48 hours after administration.
Renal clearance (CLr) of SHR8554.
Measured: 0 hour to 48 hours after administration.
Plasma protein binding rate of SHR8554 in patients with renal insufficiency.
Measured: 0 hour to 48 hours after administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2025
- Study start20 Sep 2022
- Primary completion13 Apr 2023
- Study completion13 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate to Severe Postoperative PainStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07189962
- Sponsor's protocol ID
- SHR8554-106
- Status last verified
- Sep 2025
- First submitted
- 17 Sep 2025
- Last updated
- 24 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pharmacokinetic Study of SHR8554 Injection in Chinese Patients With Renal Insufficiency and Healthy Subjects
- ClinicalTrials.gov ID
- NCT07189962
- Acronym / sponsor ID
- SHR8554-106
- Conditions
- Moderate to Severe Postoperative Pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Sep 2022 (actual)
- Primary completion
- 13 Apr 2023 (actual)
- Study completion
- 13 Apr 2023 (actual)
- First posted
- 24 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is being conducted to evaluate the safety and pharmacokinetic characteristics of SHR8554 injection in subjects with renal insufficiency and healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal renal function group | Experimental | Drug: SHR8554 Injection |
| Severe renal dysfunction group | Experimental | Drug: SHR8554 Injection |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SHR8554 InjectionSHR8554 injection. | Drug | Normal renal function group, Severe renal dysfunction group |
Primary outcome
Maximum observed concentration of SHR8554 (Cmax).
Time frame: 0 hour to 48 hours after administration.
Area under the serum concentration time curve (AUC) of SHR8554.
Time frame: 0 hour to 48 hours after administration.
Half-life (t1/2) of SHR8554.
Time frame: 0 hour to 48 hours after administration.
Clearance (CL) of SHR8554.
Time frame: 0 hour to 48 hours after administration.
Volume of distribution (Vz) of SHR8554.
Time frame: 0 hour to 48 hours after administration.
4 secondary outcomes
Cumulative excretion (Ae) of SHR8554.
Time frame: 0 hour to 48 hours after administration.
Urinary excretion fraction (fe) of SHR8554.
Time frame: 0 hour to 48 hours after administration.
Renal clearance (CLr) of SHR8554.
Time frame: 0 hour to 48 hours after administration.
Plasma protein binding rate of SHR8554 in patients with renal insufficiency.
Time frame: 0 hour to 48 hours after administration.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SHR8554 Injection in people with Moderate to Severe Postoperative Pain, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum observed concentration of SHR8554 (Cmax). (time frame: 0 hour to 48 hours after administration.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2025.