A Study to Evaluate the Pharmacokinetics of HSK21542 in Subjects With Renal Impairment

NCT ID: NCT05947097

Last Updated: 2023-07-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-24
• Study Completion Date: 2023-12-30

Brief Summary

This is an open-label, single-dose study to evaluate the pharmacokinetics and safety of HSK21542 in subjects with mild, moderate and severe renal impairment compared to the matched control subjects with normal renal function.

Conditions

Renal Impairment

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mild Renal Impairment

Group Type: EXPERIMENTAL

HSK21542 Injection

Intervention Type: DRUG

1ug/kg bolus for 2min±5s

Moderate Renal Impairment

Group Type: EXPERIMENTAL

HSK21542 Injection

Intervention Type: DRUG

1ug/kg bolus for 2min±5s

Severe Renal Impairment

Group Type: EXPERIMENTAL

HSK21542 Injection

Intervention Type: DRUG

1ug/kg bolus for 2min±5s

Normal Renal function

Group Type: EXPERIMENTAL

HSK21542 Injection

Intervention Type: DRUG

1ug/kg bolus for 2min±5s

Interventions

HSK21542 Injection

1ug/kg bolus for 2min±5s

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

Subjects with renal impairment(RI):

1. Voluntarily sign the informed consent form, understand the trial procedures, and be willing to comply with all trial procedures and restrictions;

2. 18 years to 79 years (inclusive), male and female;

3. Male subjects weight ≥50 kg and female subjects weight ≥45 kg. Body mass index (BMI) : 18-30 kg/m2 (inclusive) (BMI= weight (kg)/height2 (m^2));

4. Subjects with medically stable RI until study completion corresponding to the classifications of Renal Function based on GFR: mild RI: 60≤GFR<90 mL/min; moderate RI: 30≤GFR<60 mL/min, severe RI:15≤GFR<30 mL/min;

5. Physical examination, vital sign measurements, 12-lead electrocardiogram (ECG), and clinical laboratory tests results were deemed appropriate by the investigator;

6. Not in use of any drug within 2 weeks prior to screening, except for the medication necessary for RI/ other comorbidities (last more than four weeks in good compliance);

7. Subjects (including partners) are willing to voluntarily use effective contraceptives from screening to at least 6 months after the last dose administration.

Subjects with normal renal function :

1. Voluntarily sign the informed consent form, understand the trial procedures, and be willing to comply with all trial procedures and restrictions;

2. 18 years to 79 years (inclusive), male and female, age and sex must be matched with subjects with RI;

3. Male subjects weight ≥50 kg and female subjects weight ≥45 kg, weight must be matched with subjects with RI. Body mass index (BMI) : 18-30 kg/m^2 (inclusive) (BMI= weight (kg)/height2 (m^2));

4. 90≤GFR<130 mL/min;

5. Physical examination, vital sign measurements, 12-lead electrocardiogram (ECG), and clinical laboratory tests results were deemed appropriate by the investigator;

6. Not in use of any drug within 2 weeks prior to screening, except for the medication necessary for comorbidities (last more than four weeks in good compliance);

7. Subjects (including partners) are willing to voluntarily use effective contraceptives from screening to at least 6 months after the last dose administration.

Exclusion Criteria

2. Have a history of severe and uncontrolled diseases, such as cardiovascular, respiratory, liver, gastrointestinal, endocrine, hematologic, mental/nervous systems diseases within one year prior to screening;

3. Have conditions that may affect drug absorption, distribution, metabolism, or excretion (e.g., disease, drugs or surgery);

4. Acute renal failure;

5. Smoking more than 5 cigarettes per day within 3 months prior to screening or smoking during the study;

6. Average alcohol intake is more than 14 unit per week (1unit=17.7 mL alcohol , 1 unit=357mL 5% alcohol beer, or 43mL 40% alcohol spirit, or 147mL 12% alcohol wine) within the 3 months prior to screening, or taking any alcohol during study or a positive ethanol breath test at screening;

7. Drug abuse history within 5 years prior to screening, or positive urine drug screen at screening;

8. History of high consumption of grapefruit juice, methylxanthine-rich food or beverage (such as coffee, tea, cola, chocolate, energy drinks) ,consumption of grapefruit juice, methylxanthine-rich food within 48 hours before the administration;

9. Participation in another clinical trial within 3 months before screening;

10. Blood donation (or blood loss) ≥400 mL, or receiving blood products to improve anemia within 3 months prior to the screening;

11. Aspartate aminotransferase (AST), alanine aminotransferase (ALT) > 2 × upper limit of normal, or bilirubin > 1.5 × upper limit of normal;

12. Have a positive result for hepatitis B surface antigen, hepatitis C virus antibody, human immunodeficiency virus antibody, or anti-treponema pallidum specific antibody;

13. A pregnant/lactating woman, or has a positive pregnancy test at screening or during the trial;

14. Not suitable for this study as judged by the investigator.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Haisco Pharmaceutical Group Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wei Zhao, PhD

Role: PRINCIPAL_INVESTIGATOR

Qianfoshan Hospital

Locations

Shandong Provincial Qianfoshan Hospital

Jinan, Shandong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Meixia Chen, PhD

Role: CONTACT

chenmeixia@haisco.com

028-67258779

Facility Contacts

Wei Zhao, PhD

Role: primary

0531-89268212

Other Identifiers

HSK21542-104

Identifier Type: -

Identifier Source: org_study_id