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

Hengrui Medicine

Status and phase: Completed; Phase 1

Conditions: Moderate to Severe Postoperative Pain

Treatments: Drug: SHR8554 Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT07189962

SHR8554-106

Details and patient eligibility

About

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

Enrollment: 20 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Normal renal function group

Experimental group

Treatment:

Drug: SHR8554 Injection

Severe renal dysfunction group

Experimental group

Treatment:

Drug: SHR8554 Injection