Resistant to Gram-positive, Gram-negative and Anaerobic BacteriaPhase 1NCT06672276

To Evaluate the Pharmacokinetics and Safety of TQD3606 for Injection in Subjects With Renal Insufficiency

A Phase 1 study testing TQD3606 in people with Resistant to Gram-positive, Gram-negative and Anaerobic Bacteria, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 2 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for: Resistant to Gram-positive, Gram-negative and Anaerobic Bacteria
What is being tested?: TQD3606
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 32 participants
Where: 2 sitesChina
Study dates: 20 Nov 2024to 6 May 2025
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 75 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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:

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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:
Those who have normal results of laboratory examination, physical examination, 12-lead electrocardiogram (ECG), anterolateral chest x-ray and color ultrasound during the screening period, or those who are judged to be abnormal and non-clinically significant by the investigator;
Individual glomerular filtration rate (GFR, mL/min, MDRD formula) during the screening period of subjects: GFR≥90 mL/min;

Who cannot join

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;

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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;
Drug abusers, or those who have used soft drugs (such as marijuana) within 3 months before screening, or who have taken hard drugs within 1 year before screening, or who have a positive urine drug screen at baseline;
Active hepatitis B virus (HBV) () or hepatitis C virus (HCV) infection, or human immunodeficiency virus (HIV) antibody positive; or those who are positive for treponema pallidum antibodies ;
Female subjects are lactating during the screening period or during the trial or have a positive serum pregnancy result;
Other situations that the investigator considers unsuitable for enrollment.
Renal impairment subjects were not eligible for the study if they met any of the following criteria:
Those who have participated in other clinical studies within 1 month before screening and have used any clinical investigation drugs or medical devices, the date of the last clinical study administration shall be used as the time benchmark (if it is a clinical investigation drug with a long half-life, at least 5 half-lives should be separated from the administration of this study);
Patients with acute renal failure, with a history of kidney transplantation, or subjects who require kidney transplantation or undergo any type of dialysis during the expected trial;
Obstructive urinary tract disease (e.g., urinary tract obstruction caused by urinary stones, urinary tract obstruction caused by abdominal mass lesions, etc.) or causes of renal impairment unrelated to renal parenchymal dysfunction (e.g., polycystic kidney, renal tumor, renal artery stenosis, drugs, severe infection, volume depletion, heart failure, etc.);
People with urinary incontinence;
At the time of screening, the therapeutic drugs and/or other treatment drugs for comorbidities have not met the requirements of stable medication for 1 month, or there are new drugs within 1 month (except for drugs used temporarily or intermittently, such as erythropoietin used once a month, or diuretics are temporarily required, etc.);
Systolic blood pressure ≥ 160 mmHg or ≤80 mmHg, diastolic blood pressure ≥ 100 mmHg or ≤50 mmHg, and heart rate outside the range of 50-100 beats/minute (both ends inclusive) during the screening period or baseline period;
Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2× ULN (upper limit of normal, ULN) and total bilirubin > 1.5×ULN in the screening period or baseline period; albumin< 25 g/L; Absolute neutrophil value< 1.3×109/L; Hemoglobin < 80g/L; Platelet count< 80×109/L;
Congestive heart failure with New York Heart Association(NYHA) grade III or IV, or left ventricular ejection fraction <50% at screening;
Normal subjects were excluded from the study if they met any of the following criteria:
Those who have participated in other clinical studies within 3 months before screening and have used any clinical investigation drugs or medical devices, with the date of the last clinical study administration as the time benchmark (if it is a clinical investigation drug with a long half-life, there needs to be at least 5 half-lives between it and the administration of this study);
Those who have used any drug within 14 days or 5 half-lives (whichever is longer) before dosing.

Trial locations and contacts

2 sites in 1 country.

China2 sites

The First Affiliated Hospital of Shandong First Medical University (Shandong Qianfoshan Hospital)
Jinan, Shandong, 250014
The Second Hospital of Shandong University
Jinan, Shandong, 250014

Other trials in China

About this study

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

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.

Conditions: Resistant to Gram-positive, Gram-negative and Anaerobic Bacteria
Being tested: TQD3606

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TQD3606Drug
TQD3606 is a fixed-dose combination of meropenem and avibactam. Meropenem is a carbapenem antimicrobial agent, and avibactam is a β-lactamase inhibitor.

Study groups in NCT06672276
Study group	Role	What they receive
A: Subjects with mild renal insufficiency	Active comparator	This group patients were given TQD3606 only one time Receives: Drug: TQD3606
B: Subjects with moderate renal insufficiency	Active comparator	This group patients were given TQD3606 only one time Receives: Drug: TQD3606
C: Subjects with severe renal insufficiency	Active comparator	This group patients were given TQD3606 only one time Receives: Drug: TQD3606
D: Health volunteers	Active comparator	This group patients were given TQD3606 only one time Receives: Drug: TQD3606

What is being measured

The primary outcome is the main question the study is designed to answer.

Peak concentration (Cmax)
Peak blood drug concentration of meropenem and avibactam.
Measured: Before administration, 0.5, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24 hours after administration
Area under the concentration-time curve (AUC)
The area under the time curve of the plasma concentration -time curve of meropenem and avibactam.
Measured: Before administration, 0.5, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24 hours after administration
Time-to-maximum concentration (Tmax)
Time-to-maximum concentration of meropenem and avibactam.
Measured: Before administration, 0.5, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24 hours after administration
Total body clearance (CLt)
Total body clearance of meropenem and avibactam.
Measured: Before administration, 0.5, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24 hours after administration
Renal clearance (CLr)
Renal clearance of meropenem and avibactam.
Measured: Before administration, 0.5, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24 hours after administration
Apparent volume of distribution (Vd/F)
Volume of distribution based on the terminal phase of meropenem and avibactam.
Measured: Before administration, 0.5, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24 hours after administration
Terminal elimination rate (λz)
First-order rate constant associated with the terminal (log-linear) elimination phase of meropenem and avibactam.
Measured: Before administration, 0.5, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24 hours after administration
Mean residence time (MRT)
The average time that the drug stays in the body of meropenem and avibactam.
Measured: Before administration, 0.5, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24 hours after administration

Secondary outcomes (2)

Amount Excreted in Urine as Unchanged Drug or Metabolite (Ae0-24)
Ae0-24 of meropenem and avibactam.
Measured: 0h before administration and 0-4, 4-8, 8-12, 12-24, 24-36, 36-48 hours after 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 72 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Nov 20246 May 2025

First posted4 Nov 2024
Study start20 Nov 2024
Primary completion6 May 2025
Study completion6 May 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Resistant to Gram-positive, Gram-negative and Anaerobic BacteriaStudies 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: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06672276
Sponsor's protocol ID: TQD3606-I-03
Status last verified: Nov 2025
First submitted: 31 Oct 2024
Last updated: 9 Jan 2026
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 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open, Parallel, Single-dose Phase I Clinical Study to Evaluate the Pharmacokinetics and Safety of TQD3606 for Injection in Subjects With Renal Insufficiency
ClinicalTrials.gov ID: NCT06672276
Acronym / sponsor ID: TQD3606-I-03
Conditions: Resistant to Gram-positive, Gram-negative and Anaerobic Bacteria
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
Study start: 20 Nov 2024 (actual)
Primary completion: 6 May 2025 (actual)
Study completion: 6 May 2025 (actual)
First posted: 4 Nov 2024 (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.

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.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
A: Subjects with mild renal insufficiency	Active comparator	Drug: TQD3606This group patients were given TQD3606 only one time
B: Subjects with moderate renal insufficiency	Active comparator	Drug: TQD3606This group patients were given TQD3606 only one time
C: Subjects with severe renal insufficiency	Active comparator	Drug: TQD3606This group patients were given TQD3606 only one time
D: Health volunteers	Active comparator	Drug: TQD3606This group patients were given TQD3606 only one time

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

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;

Key exclusion criteria (26 listed)

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;

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
TQD3606TQD3606 is a fixed-dose combination of meropenem and avibactam. Meropenem is a carbapenem antimicrobial agent, and avibactam is a β-lactamase inhibitor.	Drug	A: Subjects with mild renal insufficiency, B: Subjects with moderate renal insufficiency, C: Subjects with severe renal insufficiency, D: Health volunteers

Primary outcome

Peak concentration (Cmax)
Time frame: Before administration, 0.5, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24 hours after administration
Peak blood drug concentration of meropenem and avibactam.
Area under the concentration-time curve (AUC)
Time frame: Before administration, 0.5, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24 hours after administration
The area under the time curve of the plasma concentration -time curve of meropenem and avibactam.
Time-to-maximum concentration (Tmax)
Time frame: Before administration, 0.5, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24 hours after administration
Time-to-maximum concentration of meropenem and avibactam.
Total body clearance (CLt)
Time frame: Before administration, 0.5, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24 hours after administration
Total body clearance of meropenem and avibactam.
Renal clearance (CLr)
Time frame: Before administration, 0.5, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24 hours after administration
Renal clearance of meropenem and avibactam.
Apparent volume of distribution (Vd/F)
Time frame: Before administration, 0.5, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24 hours after administration
Volume of distribution based on the terminal phase of meropenem and avibactam.
Terminal elimination rate (λz)
Time frame: Before administration, 0.5, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24 hours after administration
First-order rate constant associated with the terminal (log-linear) elimination phase of meropenem and avibactam.
Mean residence time (MRT)
Time frame: Before administration, 0.5, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24 hours after administration
The average time that the drug stays in the body of meropenem and avibactam.

2 secondary outcomes

Amount Excreted in Urine as Unchanged Drug or Metabolite (Ae0-24)
Time frame: 0h before administration and 0-4, 4-8, 8-12, 12-24, 24-36, 36-48 hours after administration
Adverse event rate
Time frame: Baseline up to 72 hours

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.

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.

The record lists no contact. Use the official record to reach the sponsor.

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing TQD3606 in people with Resistant to Gram-positive, Gram-negative and Anaerobic Bacteria, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 2 sites 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 12 inclusion and 26 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: finished, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Peak concentration (Cmax) (time frame: Before administration, 0.5, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24 hours after administration). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06672276.

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 9 Jan 2026.