Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Kidney patients needed for pain drug study

NCT ID NCT07189962

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Moderate to severe postoperative pain are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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

More trials for these conditions

Other studies related to the condition(s) this trial covers.