Metabolism and Excretory of HSK21542 in Maintenance Hemodialysis Patients

NCT06238388 | Completed Phase 1

• 1 other identifier: HSK21542-105
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Kidney Disease Patients

Outcome Measures

Primary Outcomes (8)

• Cumulative recovery of unchanged drug (Ae)

  The pharmacokinetic parameters of HSK21542 in urine, feces, and dialysate

  From the start of administration to 168 hours after administration

• Cumulative recovery fraction of unchanged drug (Fe)

  The pharmacokinetic parameters of HSK21542 in urine, feces, and dialysate

  From the start of administration to 168 hours after administration

• Plasma clearance

  The pharmacokinetic parameters of HSK21542 in urine, feces, and dialysate

  From the start of administration to 168 hours after administration

• Cmax

  The pharmacokinetic parameters of HSK21542 in plasma

  From the start of administration to 168 hours after administration

• AUC(0-t)

  The pharmacokinetic parameters of HSK21542 in plasma

  From the start of administration to 168 hours after administration

• AUC(0-∞)

  The pharmacokinetic parameters of HSK21542 in plasma

  From the start of administration to 168 hours after administration

• Tmax

  The pharmacokinetic parameters of HSK21542 in plasma

  From the start of administration to 168 hours after administration

• t1/2

  The pharmacokinetic parameters of HSK21542 in plasma

  From the start of administration to 168 hours after administration

Secondary Outcomes (2)

• The main metabolites of HSK21542

  From the start of administration to 168 hours after administration

• Adverse events (AEs)

  From after administration to the end of telephone follow-up

Study Arms (1)

0.8 μg/kg HSK21542 Injection

EXPERIMENTAL

0.8 μg/kg HSK21542 Injection

Drug: HSK21542 Injection

Interventions

HSK21542 Injection DRUG

A single intravenous dose of 0.8 μg/kg HSK21542 in boluses after D1 dialysis completed.

0.8 μg/kg HSK21542 Injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• Expected to undergo kidney transplantation and/or parathyroidectomy during the 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;
• Females who are pregnant or breastfeeding;
• Smoking an average of more than 5 cigarettes per day within the first 3 months of screening, or not stopping the use of any tobacco products during the trial period;
• Any physiological or psychological diseases or conditions that may increase the risk of the trial, affect the subject's compliance with the protocol, or affect the subject's completion of the trial, as judged by the study physician, including but not limited to:
• Known or suspected alcohol, anesthetic, or other substance abuse or drug dependence history within the first 12 months of screening; Baseline urine drug screening (if any) or positive alcohol breath test;
• severe systolic or diastolic heart failure within the first 6 months of screening (e.g. NYHA grade IV congestive heart failure (NYHA heart function grading criteria can be found in Appendix 3) ;
• Severe mental illness or cognitive impairment (e.g., dementia);

Sponsors & Collaborators

• Haisco Pharmaceutical Group Co., Ltd.: lead

Study Sites (1)

The First Affiliated Hospital of Shandong First Medical University (Shandong Provincial Qianfoshan Hospital)

Jinan, Shandong, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2024
• First Posted: February 2, 2024
• Study Start: October 10, 2023
• Primary Completion: November 21, 2023
• Study Completion: February 27, 2024
• Last Updated: August 20, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)