Kidney patients needed for pain drug study
NCT ID NCT07189962
First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time
Summary
This completed Phase 1 study looked at how the drug SHR8554 injection behaves in 20 people with kidney problems compared to healthy volunteers. The goal was to measure drug levels and safety, not to treat pain. Results will help guide future dosing for patients with kidney issues.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- SHR8554 injection
- What this could lead to
- If successful, this could help doctors understand how to dose SHR8554 safely for people with kidney problems.
- What could go wrong
- This is a very early, small study (20 people) focused on drug levels, not on treating pain. It may not lead to any new treatment.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
20 people
The number who actually took part.
- Started
-
Sep 2022
- Finished
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Apr 2023
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266003, China
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