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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-20

Study Completion Date

2023-04-13

Brief Summary

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

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Detailed Description

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Conditions

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Moderate to Severe Postoperative Pain

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Normal renal function group

Group Type EXPERIMENTAL

SHR8554 Injection

Intervention Type DRUG

SHR8554 injection.

Severe renal dysfunction group

Group Type EXPERIMENTAL

SHR8554 Injection

Intervention Type DRUG

SHR8554 injection.

Interventions

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SHR8554 Injection

SHR8554 injection.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes