To Evaluate the Pharmacokinetic Effects of TQD3606 for Injection in Healthy Adult Subjects

• Status: Not yet recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

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 single center, randomized, double-blind, placebo-controlled, single and multiple administration in healthy subjects, and to explore the excretion of TQD3606 in urine. To evaluate the tolerability and safety of injectable TQD3606 after single and multiple dosing in healthy subjects.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
• Treatments: Avibactam; Meropenem

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.