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

NCT ID: NCT05340530

Last Updated: 2022-04-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-30
• Study Completion Date: 2023-12-31

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 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.

Conditions

Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

The injectable TQD3606

received a single dose of 0.75g TQD3606 for injection

Group Type: EXPERIMENTAL

The injectable TQD3606

Intervention Type: DRUG

TQD3606 is a fixed-dose combination of meropenem and avibatam.

The injectable TQD3606+ meropenem

First, a single dose of 0.5g of meropenem for injection was administered for 0.5h intravenous infusion; after washout for at least 2 days, 0.75g of TQD3606 for injection was administered for 1h intravenous infusion; for at least 2 days of washout, 0.75g was administered A single dose of TQD3606 for injection was administered for 2 hours, and the elution time was at least 2 days. Finally, a single dose of 0.75 g of TQD3606 for injection was administered, and the duration of intravenous infusion was 3 hours.

Group Type: ACTIVE_COMPARATOR

The injectable TQD3606

Intervention Type: DRUG

TQD3606 is a fixed-dose combination of meropenem and avibatam.

meropenem

Intervention Type: DRUG

Meropenem is a carbapenem antibiotic

The injectable TQD3606+ meropenem+ Avibactam Sodium

According to the random table, they were divided into two groups, A and B, Group A was given 1.0g meropenem for injection (Mepin) in the first cycle, and 0.5g avibactam sodium for injection in the second cycle. The third cycle was given 1.5g TQD3606 for injection; group B was given 0.5g avibactam sodium for injection in the first cycle, 1.0g meropenem (Mepin) for injection in the second cycle, and 1.5g for injection in the third cycle TQD3606.

Group Type: ACTIVE_COMPARATOR

The injectable TQD3606

Intervention Type: DRUG

TQD3606 is a fixed-dose combination of meropenem and avibatam.

meropenem

Intervention Type: DRUG

Meropenem is a carbapenem antibiotic

Avibactam Sodium

Intervention Type: DRUG

Avibactam is beta-lactamase inhibitor.

The injectable TQD3606-1

First, 0.75g TQD3606 for injection was administered multiple times (Dosing every 8 hours, 3 consecutive doses), and at least 2 days were washed out after the last dose; then 1.125g TQD3606 for injection was administered multiple times (Dosing every 12 hours, 2 consecutive doses) times), wash out at least 2 days after the last administration; finally, a single administration of 2.25 g of TQD3606 for injection (Dosing every 12 hours, once administered). Intravenous infusion for 3 hours.

Group Type: EXPERIMENTAL

The injectable TQD3606

Intervention Type: DRUG

TQD3606 is a fixed-dose combination of meropenem and avibatam.

The injectable TQD3606/ Placebo

First, a single dose of 3.0g TQD3606 for injection/placebo was administered, intravenous infusion for 3hours, and washout for at least 3 days; then multiple doses of 3.0g TQD3606 for injection/placebo were administered (Dosing every 8 hours, 10 consecutive doses) , the intravenous infusion duration is 3hours.

Group Type: PLACEBO_COMPARATOR

The injectable TQD3606

Intervention Type: DRUG

TQD3606 is a fixed-dose combination of meropenem and avibatam.

Placebo

Intervention Type: DRUG

It is a placebo.

Interventions

The injectable TQD3606

TQD3606 is a fixed-dose combination of meropenem and avibatam.

Intervention Type: DRUG

meropenem

Meropenem is a carbapenem antibiotic

Intervention Type: DRUG

Avibactam Sodium

Avibactam is beta-lactamase inhibitor.

Intervention Type: DRUG

Placebo

It is a placebo.

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Affiliated Hospital of Changchun University of Traditional Chinese Medicine

Changchun, Jilin, China

Countries

China

Central Contacts

Haimiao Yang, Master

Role: CONTACT

czfyyq728@163.com

0431-86177635

Facility Contacts

Haimiao Yang, Master

Role: primary

0431-86177635

Role: backup

czfyyq728@163.com

Other Identifiers

TQD3606-I-01

Identifier Type: -

Identifier Source: org_study_id