A Phase I Clinical Trial Exploring the Metabolic and Excretion Characteristics of HSK21542 Injection in Maintenance Hemodialysis Patients

Haisco Pharmaceutical Group Co., Ltd.1 site in 1 country6 target enrollmentOctober 10, 2023

ConditionsChronic Kidney Disease Patients

InterventionsHSK21542 Injection

DrugsHSK21542 Injection

Overview

Phase: Phase 1
Intervention: HSK21542 Injection
Conditions: Chronic Kidney Disease Patients
Sponsor: Haisco Pharmaceutical Group Co., Ltd.
Enrollment: 6
Locations: 1
Primary Endpoint: Cumulative recovery of unchanged drug (Ae)
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a single-center, nonrandomized, and open design study to investigate metabolism and excretion of HSK21542 in maintenance hemodialysis patients.

Registry

clinicaltrials.gov

Start Date

October 10, 2023

End Date

February 27, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Haisco Pharmaceutical Group Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subjects who are willing to sign an informed consent form, fully understand the objectives and purposes of the study, and are willing to comply with the study protocol before any of the study-related procedures start.
•Age ≥18 years old, Male or female;
•Patients with end-stage renal diseases who receive hemodialysis (including hemodiafiltration) 3 times in a week prior to screening for at least 3 months;
•Dry weight is 40.0-135.0 kg (inclusive) during the screening period;
•Patients with at least two occurrences of single-compartment urea clearance (sp Kt/V) ≥ 1.2, or at least two occurrences of urea reduction ratio (URR) ≥ 65%, or one occurrence of sp Kt/V ≥ 1.2 and one occurrence of URR ≥ 65% on different days of dialysis within 6 months before administration;
•Female of childbearing age or Male must agree to adopt efficient contraceptive measures in sexual intercourse during the study period and within 3 months after the last administration; Menopausal female subjects should have had menopause at least one year or should have had permanent sterilization (e.g., fallopian tube occlusion, hysterectomy, bilateral salpingectomy).

Exclusion Criteria

•Expected to undergo kidney transplantation and/or parathyroidectomy during the study;
•History of allergy to opioids, such as urticaria (Note: adverse effects related to opioid use, such as constipation and nausea, are not included as the exclusion criteria in this study);
•Used opioids within 7 days before screening, or unable to avoid the use of opioids other than the investigational product during the study;
•Participated in any clinical trial of other drug or medical device within 1 month before screening (received study medication or treated by the medical device in the clinical trial);
•Used blood perfusion during the screening period or expected study period;
•Blood pressure of upper limbs in the supine position at screening: systolic blood pressure \< 90 mmHg, or diastolic blood pressure \< 60 mmHg, or systolic blood pressure \> 180 mmHg, or diastolic blood pressure \> 110 mmHg;
•Alanine aminotransferase (ALT) or aspartate aminotransferase (AST)≥ 2.5 × upper limit of normal (ULN), or total bilirubin ≥ 2 × upper limit of normal (ULN) at screening;
•Blood sodium \> 155 mmol/L at screening;
•Blood donation (or loss) ≥ 400 mL within the first 3 months of screening or Hemoglobin \< 80 g/L at screening;
•Positive for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCVAb), syphilis antibody, or human immunodeficiency virus (HIV) antibody;

Arms & Interventions

0.8 μg/kg HSK21542 Injection

Intervention: HSK21542 Injection