InfectionsPhase 1NCT05340530
To Evaluate the Pharmacokinetic Effects of TQD3606 for Injection in Healthy Adult Subjects
A Phase 1 study testing The injectable TQD3606, meropenem and Avibactam Sodium in people with Infections, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Infections
- What is being tested?
- The injectable TQD3606, meropenem and Avibactam Sodium
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteChina
- Study dates
- Apr 2022to Dec 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Affiliated Hospital of Changchun University of Traditional Chinese Medicine
Changchun, Jilin, 130103
Haimiao Yang, Master, 0431-86177635
czfyyq728@163.com
About this study
Official title: Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Characteristics of Injectable TQD3606 in a Single Center, Randomized, Double-blind, Placebo-controlled, Single, Multiple Dosing in Healthy Subjects, and to Explore Urinary Excretion of the Product
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
- Being tested
- The injectable TQD3606, meropenem, Avibactam Sodium, Placebo
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The injectable TQD3606Drug
TQD3606 is a fixed-dose combination of meropenem and avibatam.
meropenemDrug
Meropenem is a carbapenem antibiotic
Avibactam SodiumDrug
Avibactam is beta-lactamase inhibitor.
PlaceboDrug
It is a placebo.
| Study group | Role | What they receive |
|---|---|---|
| The injectable TQD3606 | Experimental | received a single dose of 0.75g TQD3606 for injection Receives: Drug: The injectable TQD3606 |
| The injectable TQD3606+ meropenem | Active comparator | 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. Receives: Drug: The injectable TQD3606; Drug: meropenem |
| The injectable TQD3606+ meropenem+ Avibactam Sodium | Active comparator | 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. Receives: Drug: The injectable TQD3606; Drug: meropenem; Drug: Avibactam Sodium |
| The injectable TQD3606-1 | Experimental | 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. Receives: Drug: The injectable TQD3606 |
| The injectable TQD3606/ Placebo | Placebo comparator | 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. Receives: Drug: The injectable TQD3606; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Concentration (Cmax)
Maximum Concentration
Measured: 1 hour before administration，to 24 hours after administration.
Area under the plasma concentration-time curve from initial dosing to 24 hours (AUC0-24)
Area under the plasma concentration-time curve from initial dosing to 24 hours
Measured: 1 hour before administration，to 24 hours after administration.
Secondary outcomes (18)
Time to maximum concentration following drug administration (Tmax)
Time to maximum concentration following drug administration
Measured: 1 hour before administration，to 24 hours after administration.
Apparent terminal elimination half-life following drug administration (t1/2)
Apparent terminal elimination half-life following drug administration
Measured: 1 hour before administration，to 24 hours after administration.
Area under plasma concentration-time curve from first dosing to last measurable concentration point (AUC0-t)
Area under plasma concentration-time curve from first dosing to last measurable concentration point
Measured: 1 hour before administration，to 24 hours after administration.
The amount of drug excreted through urine 24 hours after administration (Ae0-24)
The amount of drug excreted through urine 24 hours after administration
Measured: 1 hour before administration，to 24 hours after administration.
Cumulative excretion rate of drugs through urine
Cumulative excretion rate of drugs through urine
Measured: 1 hour before administration，to 24 hours after administration.
The total clearance (CLt) The total clearance (CLt)
The total clearance
Measured: 1 hour before administration，to 24 hours after administration.
Renal clearance (CLr)
Renal clearance
Measured: 1 hour before administration，to 24 hours after administration.
Elimination rate constant(λz)
Elimination rate constant
Measured: 1 hour before administration，to 24 hours after administration.
Apparent volume of distribution (Vd/F)
Apparent volume of distribution
Measured: 1 hour before administration，to 24 hours after administration.
Mean residence time (MRT)
Mean residence time
Measured: 1 hour before administration，to 24 hours after administration.
Valley concentration (Cmin,ss)
Valley concentration
Measured: Within 60 minutes before 8th to 10th administration and 24 hours after 10th administration
Accumulation index
Accumulation index
Measured: Within 60 minutes before 8th to 10th administration and 24 hours after 10th administration
Adverse event rate
The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs).
Measured: Baseline up to 24 hours after administration
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Monitor the safety indicators of subjects during the trial
Measured: Baseline up to 24 hours after administration
Body temperature
Monitor the safety indicators of subjects during the trial
Measured: 1 hour before administration and 24 hours after administration
Pulse
Monitor the safety indicators of subjects during the trial
Measured: 1 hour before administration and 24 hours after administration
Systolic and diastolic blood pressure
Monitor the safety indicators of subjects during the trial
Measured: 1 hour before administration and 24 hours after administration
Number of participants with abnormal laboratory test results
Monitor the safety indicators of subjects during the trial
Measured: Baseline up to 24 hours after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2022
- Study startApr 2022 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfectionsStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05340530
- Sponsor's protocol ID
- TQD3606-I-01
- Status last verified
- Apr 2022
- First submitted
- 1 Apr 2022
- Last updated
- 22 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Characteristics of Injectable TQD3606 in a Single Center, Randomized, Double-blind, Placebo-controlled, Single, Multiple Dosing in Healthy Subjects, and to Explore Urinary Excretion of the Product
- ClinicalTrials.gov ID
- NCT05340530
- Acronym / sponsor ID
- TQD3606-I-01
- Conditions
- Infections
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2022 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 22 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| The injectable TQD3606 | Experimental | Drug: The injectable TQD3606received a single dose of 0.75g TQD3606 for injection |
| The injectable TQD3606+ meropenem | Active comparator | Drug: The injectable TQD3606, Drug: meropenemFirst, 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. |
| The injectable TQD3606+ meropenem+ Avibactam Sodium | Active comparator | Drug: The injectable TQD3606, Drug: meropenem, Drug: Avibactam SodiumAccording 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. |
| The injectable TQD3606-1 | Experimental | Drug: The injectable TQD3606First, 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. |
| The injectable TQD3606/ Placebo | Placebo comparator | Drug: The injectable TQD3606, Drug: PlaceboFirst, 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (20 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The injectable TQD3606TQD3606 is a fixed-dose combination of meropenem and avibatam. | Drug | The injectable TQD3606, The injectable TQD3606+ meropenem, The injectable TQD3606+ meropenem+ Avibactam Sodium, The injectable TQD3606-1, The injectable TQD3606/ Placebo |
| meropenemMeropenem is a carbapenem antibiotic | Drug | The injectable TQD3606+ meropenem, The injectable TQD3606+ meropenem+ Avibactam Sodium |
| Avibactam SodiumAvibactam is beta-lactamase inhibitor. | Drug | The injectable TQD3606+ meropenem+ Avibactam Sodium |
| PlaceboIt is a placebo. | Drug | The injectable TQD3606/ Placebo |
Primary outcome
Maximum Concentration (Cmax)
Time frame: 1 hour before administration，to 24 hours after administration.
Maximum Concentration
Area under the plasma concentration-time curve from initial dosing to 24 hours (AUC0-24)
Time frame: 1 hour before administration，to 24 hours after administration.
Area under the plasma concentration-time curve from initial dosing to 24 hours
18 secondary outcomes
Time to maximum concentration following drug administration (Tmax)
Time frame: 1 hour before administration，to 24 hours after administration.
Apparent terminal elimination half-life following drug administration (t1/2)
Time frame: 1 hour before administration，to 24 hours after administration.
Area under plasma concentration-time curve from first dosing to last measurable concentration point (AUC0-t)
Time frame: 1 hour before administration，to 24 hours after administration.
The amount of drug excreted through urine 24 hours after administration (Ae0-24)
Time frame: 1 hour before administration，to 24 hours after administration.
Cumulative excretion rate of drugs through urine
Time frame: 1 hour before administration，to 24 hours after administration.
The total clearance (CLt) The total clearance (CLt)
Time frame: 1 hour before administration，to 24 hours after administration.
Renal clearance (CLr)
Time frame: 1 hour before administration，to 24 hours after administration.
Elimination rate constant(λz)
Time frame: 1 hour before administration，to 24 hours after administration.
Apparent volume of distribution (Vd/F)
Time frame: 1 hour before administration，to 24 hours after administration.
Mean residence time (MRT)
Time frame: 1 hour before administration，to 24 hours after administration.
Valley concentration (Cmin,ss)
Time frame: Within 60 minutes before 8th to 10th administration and 24 hours after 10th administration
Accumulation index
Time frame: Within 60 minutes before 8th to 10th administration and 24 hours after 10th administration
Adverse event rate
Time frame: Baseline up to 24 hours after administration
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: Baseline up to 24 hours after administration
Body temperature
Time frame: 1 hour before administration and 24 hours after administration
Pulse
Time frame: 1 hour before administration and 24 hours after administration
Systolic and diastolic blood pressure
Time frame: 1 hour before administration and 24 hours after administration
Number of participants with abnormal laboratory test results
Time frame: Baseline up to 24 hours after administration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing The injectable TQD3606, meropenem and Avibactam Sodium in people with Infections, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Haimiao Yang, Master (0431-86177635, czfyyq728@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Concentration (Cmax) (time frame: 1 hour before administration，to 24 hours after administration.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2022.