Multi-resistant Gram-negative Bacteria Cause InfectionPhase 1NCT06522945
To Evaluate the Pharmacokinetics and Safety of TQD3524 for Injection in Renal Impairment Subjects
A Phase 1 study testing TQD3524 in people with Multi-resistant Gram-negative Bacteria Cause Infection, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 1 site in China.
Trial summary
This is an open, open-label, parallel, single-dose, phase I clinical study designed to evaluate the pharmacokinetic (PK) profile of TQD3524 injection in patients with renal impairment after a single dose, and to evaluate the urinary excretion of the drug in these patients after a single dose, as well as to evaluate… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Multi-resistant Gram-negative Bacteria Cause Infection
- What is being tested?
- TQD3524
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 24 Jul 2024to 18 Dec 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 6 months from screening 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;
- 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, chronic kidney disease stage 2 (CKD2) period), or 30≤GFR≤59 mL/min (Group B, moderate renal dysfunction, chronic kidney disease stage 3 (CKD3) period), or 15≤GFR≤29 mL/min (Group C, severe renal dysfunction, chronic kidney disease stage 4 (CKD4) period), or GFR<15 mL/min (Group D, end-stage renal disease, not on dialysis; Group E, end-stage renal disease, on dialysis);
- For normal subjects, also required meet all of the following criteria for inclusion in this study:
- During the screening period, normal vital signs, laboratory tests, physical examination, 12-lead ECG, chest radiographs, and echocardiography results, or abnormal results determined by the investigator to be of no clinical significance, are considered normal.
Who cannot join
- All subjects were not eligible for the study if they met any of the following criteria:
- Individuals with an allergy disposition, or those with a history of allergic reactions to polymyxin-type drugs (including polymyxin B, polymyxin sulfate, and polymyxin E monosodium salt);
- Participants who have had any type of treatment or untreated malignant tumor (excluding basal cell carcinoma of the skin) within the past 5 years or at baseline;
- Participants who have had a serious digestive, respiratory, nervous, hematological, endocrine, tumor, immune, psychological, or cardiovascular disease within the past year and are deemed unfit for the study by the investigator;
- Participants who have had a major illness or surgery within the past 4 weeks or plan to undergo surgery during the study period;
- Participants who have donated blood (or lost blood) of at least 400 mL within the past 3 months or have received blood products;
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- Participants who have smoked an average of more than 10 cigarettes per day within the past 3 months;
- Participants who have consumed an average of more than 14 units (female subjects) or 21 units (male subjects) of alcohol per week within the past 3 months (1 unit = 285 mL of beer, 25 mL of distilled spirits, or 100 mL of wine);
- Participants who have consumed a special diet (including dragon fruit, mango, grapefruit, and/or xanthine diet, chocolate) and/or consumed excessive tea, coffee, grapefruit/grapefruit juice, and/or caffeine-containing beverages (an average of 8 cups or more per day, 200 mL per cup) within the past 2 weeks;
- Participants who have consumed any alcoholic beverages within 48 hours of receiving the study drug or who have a positive breath alcohol test; 10) Individuals with a history of drug abuse within the past 5 years, or who have used soft drugs (e.g. marijuana) within the past 3 months, or who have used hard drugs within the past year, or who have a positive drug screen at baseline (if urine is available, screen for end-stage renal disease);
- Individuals with positive HIV antibody; positive hepatitis C virus (HCV) antibody or HBsAg positive; positive syphilis treponemal antibody;
- Pregnant or lactating women, and women of childbearing potential with a positive pregnancy test result;
- Individuals who have used strong inhibitors or inducers of liver metabolizing enzymes within the past 14 days;
- Other situations that the investigator considers inappropriate for enrollment.
- Renal impairment subjects were not eligible for the study if they met any of the following criteria:
- With acute renal failure, has a history of renal transplantation, or expected during the test need a kidney transplant or accept any type of dialysis patients;
- With obstructive urinary tract diseases (such as urinary tract obstruction caused by urinary calculi, abdominal space occupying lesions, etc.) or causes of renal damage unrelated to renal parenchymal dysfunction (such as polycystic kidney disease, renal tumor, renal artery stenosis, drugs, severe infection, hypovolemia, heart failure, etc.);
- Patients with urinary incontinence;
- Screening, treatment and/or other drug combined treatment of diseases have not meet a month stability, within a month or a new medication (except for temporary or intermittent use of drugs, such as a month use erythropoietin, or temporary require the use of diuretics, etc.);
- Congestive heart failure of New York Heart Association (NYHA) class III or IV, or left ventricular ejection fraction <50% at screening;
- On the stage screening or baseline, systolic blood pressure 160 mmHg and 80 mmHg or less, or diastolic blood pressure 100 mmHg or 50 mmHg or less, or heart rate < 50 times/min or > 100 times/min;
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2×Up Limit of Normal(ULN), total bilirubin >1.5×ULN; Albumin < 25 g/L; Absolute neutrophil count <1.0×109/L; Hemoglobin < 80 g/L; The platelet count < 75 x 109 / L; 2) Participants who were enrolled in another clinical trial and used any investigational drug or medical device within 1 month before screening, based on the last investigational drug administration date (at least 5 half-lives between investigational drug administration and this study administration for long-half-life investigational drug);
- Normal subjects were excluded from the study if they met any of the following criteria:
- Participants who were enrolled in other clinical trials and used any investigational drug or device within 3 months before screening, based on the date of last investigational drug administration (for investigational drug with long half-life, at least 5 half-life intervals between investigational drug administration and this study);
- For 14 days before or within 5 half-life of longer (to) the use of any drugs.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital)
Jinan, Shandong, 250000
About this study
Official title: An Open, Parallel, Single-dose Phase I Clinical Study on the Pharmacokinetics and Safety of TQD3524 for Injection in Renal Impairment Subjects
This is an open, open-label, parallel, single-dose, phase I clinical study designed to evaluate the pharmacokinetic (PK) profile of TQD3524 injection in patients with renal impairment after a single dose, and to evaluate the urinary excretion of the drug in these patients after a single dose, as well as to evaluate the safety of the drug in these patients after a single dose.
- Being tested
- TQD3524
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TQD3524Drug
Polymyxin antibiotics
TQD3524Drug
Polymyxin antibiotics
TQD3524Drug
Polymyxin antibiotics
TQD3524Drug
Polymyxin antibiotics
TQD3524Drug
Polymyxin antibiotics
TQD3524Drug
Polymyxin antibiotics
| Study group | Role | What they receive |
|---|---|---|
| A: Mild Renal Impairment (GFR:60~89 mL/min) | Active comparator | A: TQD3524 2.5 mg/kg administered as a 90 minute infusion via infusion pump, single dose Receives: Drug: TQD3524 |
| B: Moderate Renal Impairment (GFR:30~59 mL/min) | Active comparator | B: TQD3524 2.5 mg/kg administered as a 90 minute infusion via infusion pump, single dose Receives: Drug: TQD3524 |
| C: Severe Renal Impairment (GFR:15~29 mL/min) | Active comparator | C: TQD3524 1.25 mg/kg administered as a 90 minute infusion via infusion pump, single dose Receives: Drug: TQD3524 |
| D: End-stage renal disease (patients undialyzed ) (GFR<15 mL/min) | Active comparator | D: TQD3524 1.25 mg/kg administered as a 90 minute infusion via infusion pump, single dose Receives: Drug: TQD3524 |
| E: End-stage renal disease (patients dialyzed) (GFR<15 mL/min) | Active comparator | E: TQD3524 1.25 mg/kg administered as a 90 minute infusion via infusion pump, single dose Receives: Drug: TQD3524 |
| F: Normal (GFR≥90mL/min) | Active comparator | F: TQD3524 2.5 mg/kg administered as a 90 minute infusion via infusion pump, single dose Receives: Drug: TQD3524 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak concentration (Cmax)
Maximum plasma drug concentration
Measured: Before administration, 1.75 , 2 , 2 .5, 3.5, 5 , 7 , 9,12 , 16, 24 hours after administration
Area under the concentration-time curve (AUC)
Area under the plasma concentration-time curve
Measured: Before administration, 1.75 , 2 , 2 .5, 3.5, 5 , 7 , 9,12 , 16, 24 hours after administration
Time-to-maximum concentration (Tmax)
Time-to-maximum concentration
Measured: Before administration, 1.75 , 2 , 2 .5, 3.5, 5 , 7 , 9,12 , 16, 24 hours after administration
Plasma half life (t1/2)
The time it takes for the concentration or amount in the body of that drug to be reduced by exactly one-half
Measured: Before administration, 1.75 , 2 , 2 .5, 3.5, 5 , 7 , 9,12 , 16, 24 hours after administration
Total body clearance (CLt)
Total body clearance of TQD3524
Measured: Before administration, 1.75 , 2 , 2 .5, 3.5, 5 , 7 , 9,12 , 16, 24 hours after administration
Renal clearance (CLr)
Renal clearance of TQD3524
Measured: Before administration, 1.75 , 2 , 2 .5, 3.5, 5 , 7 , 9,12 , 16, 24 hours after administration
Apparent volume of distribution (Vd/F)
Volume of distribution based on the terminal phase
Measured: Before administration, 1.75 , 2 , 2 .5, 3.5, 5 , 7 , 9,12 , 16, 24 hours after administration
Terminal elimination rate (λz)
First-order rate constant associated with the terminal (log-linear) elimination phase
Measured: Before administration, 1.75 , 2 , 2 .5, 3.5, 5 , 7 , 9,12 , 16, 24 hours after administration
Mean residence time (MRT)
The average time that the drug stays in the body
Measured: Before administration, 1.75 , 2 , 2 .5, 3.5, 5 , 7 , 9,12 , 16, 24 hours after administration
Secondary outcomes (2)
Amount Excreted in Urine as Unchanged Drug or Metabolite (Ae0-24)
Ae0-24 of TQD3524 and the active ingredients in urine
Measured: Before administration, 1.75 , 2 , 2 .5, 3.5, 5 , 7 , 9,12 , 16, 24 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.
- First posted26 Jul 2024
- Study start24 Jul 2024
- Primary completion18 Dec 2025
- Study completion18 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multi-resistant Gram-negative Bacteria Cause InfectionStudies 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
- 48 participants (actual)
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
- NCT06522945
- Sponsor's protocol ID
- TQD3524-I-02
- Status last verified
- Dec 2025
- First submitted
- 23 Jul 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 on the Pharmacokinetics and Safety of TQD3524 for Injection in Renal Impairment Subjects
- ClinicalTrials.gov ID
- NCT06522945
- Acronym / sponsor ID
- TQD3524-I-02
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Jul 2024 (actual)
- Primary completion
- 18 Dec 2025 (actual)
- Study completion
- 18 Dec 2025 (actual)
- First posted
- 26 Jul 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.
This is an open, open-label, parallel, single-dose, phase I clinical study designed to evaluate the pharmacokinetic (PK) profile of TQD3524 injection in patients with renal impairment after a single dose, and to evaluate the urinary excretion of the drug in these patients after a single dose, as well as to evaluate the safety of the drug in these patients after a single dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| A: Mild Renal Impairment (GFR:60~89 mL/min) | Active comparator | Drug: TQD3524A: TQD3524 2.5 mg/kg administered as a 90 minute infusion via infusion pump, single dose |
| B: Moderate Renal Impairment (GFR:30~59 mL/min) | Active comparator | Drug: TQD3524B: TQD3524 2.5 mg/kg administered as a 90 minute infusion via infusion pump, single dose |
| C: Severe Renal Impairment (GFR:15~29 mL/min) | Active comparator | Drug: TQD3524C: TQD3524 1.25 mg/kg administered as a 90 minute infusion via infusion pump, single dose |
| D: End-stage renal disease (patients undialyzed ) (GFR<15 mL/min) | Active comparator | Drug: TQD3524D: TQD3524 1.25 mg/kg administered as a 90 minute infusion via infusion pump, single dose |
| E: End-stage renal disease (patients dialyzed) (GFR<15 mL/min) | Active comparator | Drug: TQD3524E: TQD3524 1.25 mg/kg administered as a 90 minute infusion via infusion pump, single dose |
| F: Normal (GFR≥90mL/min) | Active comparator | Drug: TQD3524F: TQD3524 2.5 mg/kg administered as a 90 minute infusion via infusion pump, single dose |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- All subjects are required to meet all of the following criteria for inclusion in this study:
- For renal impairment subjects, also required meet all of the following criteria for inclusion in this study:
- For normal subjects, also required meet all of the following criteria for inclusion in this study:
Key exclusion criteria (25 listed)
- All subjects were not eligible for the study if they met any of the following criteria:
- Renal impairment subjects were not eligible for the study if they met any of the following criteria:
- Normal subjects were excluded from the study if they met any of the following criteria:
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 |
|---|---|---|
| TQD3524Polymyxin antibiotics | Drug | A: Mild Renal Impairment (GFR:60~89 mL/min) |
| TQD3524Polymyxin antibiotics | Drug | B: Moderate Renal Impairment (GFR:30~59 mL/min) |
| TQD3524Polymyxin antibiotics | Drug | C: Severe Renal Impairment (GFR:15~29 mL/min) |
| TQD3524Polymyxin antibiotics | Drug | D: End-stage renal disease (patients undialyzed ) (GFR<15 mL/min) |
| TQD3524Polymyxin antibiotics | Drug | E: End-stage renal disease (patients dialyzed) (GFR<15 mL/min) |
| TQD3524Polymyxin antibiotics | Drug | F: Normal (GFR≥90mL/min) |
Primary outcome
Peak concentration (Cmax)
Time frame: Before administration, 1.75 , 2 , 2 .5, 3.5, 5 , 7 , 9,12 , 16, 24 hours after administration
Maximum plasma drug concentration
Area under the concentration-time curve (AUC)
Time frame: Before administration, 1.75 , 2 , 2 .5, 3.5, 5 , 7 , 9,12 , 16, 24 hours after administration
Area under the plasma concentration-time curve
Time-to-maximum concentration (Tmax)
Time frame: Before administration, 1.75 , 2 , 2 .5, 3.5, 5 , 7 , 9,12 , 16, 24 hours after administration
Time-to-maximum concentration
Plasma half life (t1/2)
Time frame: Before administration, 1.75 , 2 , 2 .5, 3.5, 5 , 7 , 9,12 , 16, 24 hours after administration
The time it takes for the concentration or amount in the body of that drug to be reduced by exactly one-half
Total body clearance (CLt)
Time frame: Before administration, 1.75 , 2 , 2 .5, 3.5, 5 , 7 , 9,12 , 16, 24 hours after administration
Total body clearance of TQD3524
Renal clearance (CLr)
Time frame: Before administration, 1.75 , 2 , 2 .5, 3.5, 5 , 7 , 9,12 , 16, 24 hours after administration
Renal clearance of TQD3524
Apparent volume of distribution (Vd/F)
Time frame: Before administration, 1.75 , 2 , 2 .5, 3.5, 5 , 7 , 9,12 , 16, 24 hours after administration
Volume of distribution based on the terminal phase
Terminal elimination rate (λz)
Time frame: Before administration, 1.75 , 2 , 2 .5, 3.5, 5 , 7 , 9,12 , 16, 24 hours after administration
First-order rate constant associated with the terminal (log-linear) elimination phase
Mean residence time (MRT)
Time frame: Before administration, 1.75 , 2 , 2 .5, 3.5, 5 , 7 , 9,12 , 16, 24 hours after administration
The average time that the drug stays in the body
2 secondary outcomes
Amount Excreted in Urine as Unchanged Drug or Metabolite (Ae0-24)
Time frame: Before administration, 1.75 , 2 , 2 .5, 3.5, 5 , 7 , 9,12 , 16, 24 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 TQD3524 in people with Multi-resistant Gram-negative Bacteria Cause Infection, 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 11 inclusion and 25 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 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. 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, 1.75 , 2 , 2 .5, 3.5, 5 , 7 , 9,12 , 16, 24 hours after administration). The study lists 9 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 9 Jan 2026.