Status:
UNKNOWN
To Evaluate the Pharmacokinetic Effects of TQD3606 for Injection in Healthy Adult Subjects
Lead Sponsor:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Conditions:
Infections
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
TQD3606 is a fixed-dose combination of meropenem and avibatam. This study is a phase I clinical study to evaluate the safety, tolerability and pharmacokinetic characteristics of TQD3606 injection in a...
Eligibility Criteria
Inclusion
- 1 Signed the informed consent before the test and fully understood the test content, process and possible adverse reactions;
- 2 Able to complete the research according to the requirements of the test plan;
- 3 Subjects aged between 18 and 55 (including 18 and 55);
- 4 Body mass index (BMI) ≥ 18 and ≤ 28kg/m2, with male weight ≥ 50 kg and female weight ≥ 45 kg;
- 5 Health status: No mental disorders, no history of cardiovascular system, nervous system, respiratory system, digestive system, urinary system, endocrine system and metabolic abnormalities;
- 6 Subjects had no pregnancy plan and voluntarily used effective contraceptive measures for at least 6 months from 2 weeks before self-medication to the last use of study medication.
Exclusion
- 1 Previous neuropsychiatric system, respiratory system, cardiovascular system, digestive system, hemolymph system, liver and kidney dysfunction, endocrine system, musculoskeletal system disease or other diseases, and the investigator judged that the previous history may affect drug metabolism or safety;
- 2 Known allergic history to meropenem or avitabtam, known history of anaphylactic shock to penicillin, cephalosporins, carbapenems and other β -lactam antibiotics or other severe allergic reactions (such as bullous epidermolysis atrophic dermatitis, exudative dermatitis);
- 3 Allergic constitution, including allergy to food and other drugs;
- 4 Persons with a history of epilepsy or central nervous system dysfunction;
- 5 Those with definite chronic headache or chronic diarrhea in the past;
- 6 Changes in QT interval or QT Corrected (QTc) \> 450ms were considered clinically significant by researchers;
- 7 The creatinine clearance rate was less than 50ml/min;
- 8 Taking any prescription, over-the-counter, vitamin products or herbal medicine within 2 weeks prior to screening;
- 9 Abnormal and clinically significant laboratory tests during screening period;
- 10 Blood donation or significant blood loss within 3 months prior to taking the study drug (\>450 ml);
- 11 Participated in any drug clinical trials within 3 months prior to taking the study drug;
- 12 Heavy smokers (5 cigarettes or more per day) within 3 months prior to screening;
- 13 Have a history of drug and/or alcohol abuse (14 units of alcohol per week: 1 unit =360mL beer or 45mL 40% spirits or 150mL wine);
- 14 Urine drug test positive or have a history of drug abuse or drug use in the past five years;
- 15 Unable to tolerate venipuncture blood collection or poor vascular condition;
- 16 Have taken a special diet (including dragon fruit, mango, grapefruit, grapefruit juice and/or xanthine diet) within 2 weeks prior to the trial;
- 17 Consuming chocolate, caffeinated coffee or tea within 48 hours before the trial;
- 18 Have taken any alcoholic food or beverage within 48 hours prior to the test;
- 19 The subject cannot complete the test due to personal reasons;
- 20 Conditions considered unsuitable for inclusion by other researchers.
Key Trial Info
Start Date :
April 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT05340530
Start Date
April 1 2022
End Date
December 1 2023
Last Update
April 22 2022
Active Locations (1)
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1
Affiliated Hospital of Changchun University of Traditional Chinese Medicine
Changchun, Jilin, China, 130103