An Open, Parallel, Single-dose Phase I Clinical Study to Evaluate the Pharmacokinetics and Safety of TQD3606 for Injection in Subjects With Renal Insufficiency

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.4 sites in 1 country32 target enrollmentNovember 20, 2024

ConditionsResistant to Gram-positive, Gram-negative and Anaerobic Bacteria

InterventionsTQD3606

DrugsTQD3606

Overview

Phase: Phase 1
Intervention: TQD3606
Conditions: Resistant to Gram-positive, Gram-negative and Anaerobic Bacteria
Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Enrollment: 32
Locations: 4
Primary Endpoint: Peak concentration (Cmax)
Status: Completed
Last Updated: 3 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The study is an open, parallel, single-dose phase I clinical study to evaluate the pharmacokinetics and safety of TQD3606 for injection in subjects with renal insufficiency.

Registry

clinicaltrials.gov

Start Date

November 20, 2024

End Date

May 6, 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 3 months from 2 weeks before 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(CKD);
•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, CKD2 period), or 30≤GFR≤59 mL/min (Group B, moderate renal dysfunction, CKD3 period), or 15≤GFR≤29 mL/min (Group C, severe renal dysfunction, CKD4 period).
•Subjects in the normal renal function group must also meet 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:
•Those with allergies, or known history of allergy to meropenem or avibactam, known history of anaphylactic shock or other severe allergic reactions to penicillins, cephalosporins, carbapenems and other β-lactam antibiotics (such as epidermolysis bullosa atrophic dermatitis, exfoliative dermatitis), etc.;
•Those who have any type of treated or untreated malignant tumor (whether cured or not) within 5 years before screening or in the baseline period (except for basal cell carcinoma of the skin);
•Those who have serious digestive system, respiratory system, nervous system, blood system, endocrine system, tumor, immune, psychiatric or cardiovascular and cerebrovascular diseases within 1 year before screening, and are not suitable to participate in this trial as assessed by the investigator;
•Those who have major diseases or major surgeries within 4 weeks before dosing, or those who plan to undergo surgery during the study;
•Those who have donated (or lost blood) ≥ 400 mL within 3 months before screening, or have received blood products;
•Those who smoke more than 10 cigarettes per day on average in the 3 months before screening;
•History of substance abuse within 5 years prior to screening, and/or average weekly alcohol intake of more than 14 units (female subjects) or 21 units (male subjects) in the 3 months prior to screening (1 unit = 285 mL of beer, or 25 mL of spirits, or 100 mL of wine);
•Those who have taken a special diet (including dragon fruit, mango, grapefruit, and/or xanthine diet, chocolate) and/or excessive consumption of tea, coffee, grapefruit/grapefruit juice and/or caffeinated beverages (an average of more than 8 cups per day, each cup of 200 mL) within 2 weeks before dosing;
•Those who have ingested any products containing alcohol within 48 hours before receiving the study drug, or those who have a positive alcohol breath test;

Arms & Interventions

A: Subjects with mild renal insufficiency

This group patients were given TQD3606 only one time

Intervention: TQD3606

B: Subjects with moderate renal insufficiency

This group patients were given TQD3606 only one time

Intervention: TQD3606

C: Subjects with severe renal insufficiency

This group patients were given TQD3606 only one time

Intervention: TQD3606

D: Health volunteers

This group patients were given TQD3606 only one time

Intervention: TQD3606