An Open, Parallel, Single-dose Phase I Clinical Study on the Pharmacokinetics and Safety of TQD3524 for Injection in Renal Impairment Subjects

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.1 site in 1 country48 target enrollmentJuly 24, 2024

ConditionsMulti-resistant Gram-negative Bacteria Cause Infection

InterventionsTQD3524

DrugsTQD3524

Overview

Phase: Phase 1
Intervention: TQD3524
Conditions: Multi-resistant Gram-negative Bacteria Cause Infection
Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Enrollment: 48
Locations: 1
Primary Endpoint: Area under the concentration-time curve (AUC)
Status: Completed
Last Updated: 3 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is an open, open-label, parallel, single-dose, phase I clinical study designed to evaluate the pharmacokinetic (PK) profile of TQD3524 injection in patients with renal impairment after a single dose, and to evaluate the urinary excretion of the drug in these patients after a single dose, as well as to evaluate the safety of the drug in these patients after a single dose.

Registry

clinicaltrials.gov

Start Date

July 24, 2024

End Date

December 18, 2025

Last Updated

3 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•All subjects are required to meet all of the following criteria for inclusion in this study:
•Understand the content, process and possible adverse reactions of the trial, be able to complete the study in accordance with the requirements of the trial protocol, and voluntarily sign the informed consent;
•Participants (including their partners) voluntarily used effective contraception within 6 months from screening until the last use of study drug;
•Participants aged 18 \~ 75 ;
•Body mass index (BMI) and 18 or 32 kg/m2 or less, and the male weight 50 kg or greater, female weight 45 kg or more;
•For renal impairment subjects, also required meet all of the following criteria for inclusion in this study:
•Subjects with moderate to severe renal insufficiency and end-stage renal disease were required to meet the diagnostic criteria for chronic kidney disease;
•Stable renal function: creatinine detection of at least two intervals of 3 days (30 days before the screening test results for the first time acceptable) inside and outside school or in our test result, and two detecting serum creatinine results before and after the fluctuation (calculation formula: (second results - 1)) / 1 time is less than 30%;
•During the screening period, the individual glomerular filtration rate (GFR, mL/min, using the Modification of Diet in Renal Disease (MDRD) formula, based on the results of the second serum creatinine test) was classified as follows: 60≤GFR≤89 mL/min (Group A, mild renal dysfunction, chronic kidney disease stage 2 (CKD2) period), or 30≤GFR≤59 mL/min (Group B, moderate renal dysfunction, chronic kidney disease stage 3 (CKD3) period), or 15≤GFR≤29 mL/min (Group C, severe renal dysfunction, chronic kidney disease stage 4 (CKD4) period), or GFR\<15 mL/min (Group D, end-stage renal disease, not on dialysis; Group E, end-stage renal disease, on dialysis);
•For normal subjects, also required meet all of the following criteria for inclusion in this study:

Exclusion Criteria

•All subjects were not eligible for the study if they met any of the following criteria:
•Individuals with an allergy disposition, or those with a history of allergic reactions to polymyxin-type drugs (including polymyxin B, polymyxin sulfate, and polymyxin E monosodium salt);
•Participants who have had any type of treatment or untreated malignant tumor (excluding basal cell carcinoma of the skin) within the past 5 years or at baseline;
•Participants who have had a serious digestive, respiratory, nervous, hematological, endocrine, tumor, immune, psychological, or cardiovascular disease within the past year and are deemed unfit for the study by the investigator;
•Participants who have had a major illness or surgery within the past 4 weeks or plan to undergo surgery during the study period;
•Participants who have donated blood (or lost blood) of at least 400 mL within the past 3 months or have received blood products;
•Participants who have smoked an average of more than 10 cigarettes per day within the past 3 months;
•Participants who have consumed an average of more than 14 units (female subjects) or 21 units (male subjects) of alcohol per week within the past 3 months (1 unit = 285 mL of beer, 25 mL of distilled spirits, or 100 mL of wine);
•Participants who have consumed a special diet (including dragon fruit, mango, grapefruit, and/or xanthine diet, chocolate) and/or consumed excessive tea, coffee, grapefruit/grapefruit juice, and/or caffeine-containing beverages (an average of 8 cups or more per day, 200 mL per cup) within the past 2 weeks;
•Participants who have consumed any alcoholic beverages within 48 hours of receiving the study drug or who have a positive breath alcohol test; 10) Individuals with a history of drug abuse within the past 5 years, or who have used soft drugs (e.g. marijuana) within the past 3 months, or who have used hard drugs within the past year, or who have a positive drug screen at baseline (if urine is available, screen for end-stage renal disease);

Arms & Interventions

A: Mild Renal Impairment (GFR:60~89 mL/min)

A: TQD3524 2.5 mg/kg administered as a 90 minute infusion via infusion pump, single dose

Intervention: TQD3524

B: Moderate Renal Impairment (GFR:30~59 mL/min)

B: TQD3524 2.5 mg/kg administered as a 90 minute infusion via infusion pump, single dose

Intervention: TQD3524

C: Severe Renal Impairment (GFR:15~29 mL/min)

C: TQD3524 1.25 mg/kg administered as a 90 minute infusion via infusion pump, single dose

Intervention: TQD3524

D: End-stage renal disease (patients undialyzed ) (GFR<15 mL/min)

D: TQD3524 1.25 mg/kg administered as a 90 minute infusion via infusion pump, single dose

Intervention: TQD3524

E: End-stage renal disease (patients dialyzed) (GFR<15 mL/min)

E: TQD3524 1.25 mg/kg administered as a 90 minute infusion via infusion pump, single dose

Intervention: TQD3524

F: Normal (GFR≥90mL/min)

F: TQD3524 2.5 mg/kg administered as a 90 minute infusion via infusion pump, single dose

Intervention: TQD3524