Study on Tolerance, Pharmacokinetics and Drug Interaction of YK-1169 in Healthy Volunteers
NCT ID: NCT05588531
Last Updated: 2022-10-20
Study Results
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Basic Information
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COMPLETED
PHASE1
66 participants
INTERVENTIONAL
2021-12-20
2022-04-08
Brief Summary
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Detailed Description
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A single-center, randomized, open, three-period three-crossover 3 × 3 Latin square trial design was used. To study the effect of intravenous infusion of this product, cefepime for injection or avibactam for injection on the disposition process of the drug in the human body, so as to study whether there is a pharmacokinetic drug interaction in this product.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
BASIC_SCIENCE
TRIPLE
Study Groups
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YK-1169 0.5g (containing cefepime 0.4g, avibactam 0.1g)
Four healthy subjects in group A1, two males and two females, without control, were administered the test drug
Group 1:YK-1169
YK-1169 0.5g (containing cefepime 0.4g, avibactam 0.1g) single intravenous infusion for 2 hours
YK-1169 1.25 g (containing cefepime 1.0 g and avibactam 0.25 g)
12 healthy subjects, of whom 10 subjects were administered the investigational product and 2 subjects were administered placebo, half males and half females
Group 2:YK-1169/Placebo Injection
YK-1169 1.25g (containing cefepime 1.0g, avibactam 0.25g) / placebo single intravenous infusion for 2 hours
YK-1169 2.5g (containing cefepime 2.0g and avibactam 0.5g)
12 healthy subjects, of whom 10 subjects were administered the investigational product and 2 subjects were administered placebo, half males and half females
Group 3:YK-1169/Placebo
On the first day, YK-1169 2.5 g (containing cefepime 2.0 g, avibactam 0.5g) was single intravenously infused for 2 h. On the third day, YK-1169 2.5 g (containing cefepime 2.0 g, avibactam 0.5g) was single intravenous infusion for 2 h, three times a day at 8-h intervals, until the morning dose on the tenth day
YK-1169 3.75g (containing cefepime 3.0g and avibactam 0.75g)
12 healthy subjects, of whom 10 subjects were administered the investigational product and 2 subjects were administered placebo, half males and half females
Group 4:YK-1169/Placebo
On the first day, YK-1169 3.75 g (containing cefepime 3.0 g, avibactam 0.75g) was single intravenously infused for 2 h. On the third day, YK-1169 3.75 g (containing cefepime 3.0 g, avibactam 0.75g) was single intravenous infusion for 2 h, three times a day at 8-h intervals, until the morning dose on the tenth day
YK-1169 5.0g (containing cefepime 4.0g and avibactam 1.0g)
8 healthy subjects, 6 of whom were administered the investigational product and 2 of whom were administered placebo, half males and half females
Group 5:YK-1169/Placebo Injection
YK-1169 5.0g (containing cefepime 4.0g, avibactam 1.0g) / placebo single intravenous infusion for 2 hours
Drug Interaction Studies
18 subjects (single gender not less than 1/3) were randomly divided into D1, D2 and D3 groups, 6 subjects for each group
Group 1:YK-1169
YK-1169 0.5g (containing cefepime 0.4g, avibactam 0.1g) single intravenous infusion for 2 hours
Group 6:YK-1169/Cefepime hydrochloride for injection/Avibactam for injection
YK-1169 2.5g (containing cefepime 2.0g, avibactam 0.5g)/cefepime hydrochloride for injection 2.0g/avibactam for injection 0.5g, three-cycle three-cross single intravenous infusion for 2 hours
Interventions
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Group 1:YK-1169
YK-1169 0.5g (containing cefepime 0.4g, avibactam 0.1g) single intravenous infusion for 2 hours
Group 2:YK-1169/Placebo Injection
YK-1169 1.25g (containing cefepime 1.0g, avibactam 0.25g) / placebo single intravenous infusion for 2 hours
Group 3:YK-1169/Placebo
On the first day, YK-1169 2.5 g (containing cefepime 2.0 g, avibactam 0.5g) was single intravenously infused for 2 h. On the third day, YK-1169 2.5 g (containing cefepime 2.0 g, avibactam 0.5g) was single intravenous infusion for 2 h, three times a day at 8-h intervals, until the morning dose on the tenth day
Group 4:YK-1169/Placebo
On the first day, YK-1169 3.75 g (containing cefepime 3.0 g, avibactam 0.75g) was single intravenously infused for 2 h. On the third day, YK-1169 3.75 g (containing cefepime 3.0 g, avibactam 0.75g) was single intravenous infusion for 2 h, three times a day at 8-h intervals, until the morning dose on the tenth day
Group 5:YK-1169/Placebo Injection
YK-1169 5.0g (containing cefepime 4.0g, avibactam 1.0g) / placebo single intravenous infusion for 2 hours
Group 6:YK-1169/Cefepime hydrochloride for injection/Avibactam for injection
YK-1169 2.5g (containing cefepime 2.0g, avibactam 0.5g)/cefepime hydrochloride for injection 2.0g/avibactam for injection 0.5g, three-cycle three-cross single intravenous infusion for 2 hours
Eligibility Criteria
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Inclusion Criteria
2. body mass index (BMI) 19.0-28.0 kg/m2 (including the cut-off value);
3. fully understand the purpose of the trial, basically understand the pharmacological effects of the investigational drug and possible risks, voluntarily sign the informed consent form;
4. be able to communicate well with the investigator, and understand and abide by the requirements of this study.
Exclusion Criteria
2. have a history of respiratory system, digestive system, cardiovascular system, endocrine system, urinary system, nervous system (such as epilepsy, etc.), hematology, immunology (including personal or family history of hereditary immunodeficiency), metabolic abnormalities and the investigator believes that there is still clinical significance;
3. allergic to penicillins, allergic to cephalosporins, allergic to amoxicillin clavulanate potassium tablets or their excipients, or a history of drug, food or other substance allergy;
4. can not tolerate intravenous puncture or have a history of halo, fainting needle;
5. received surgery within 6 months before the use of study drugs that will affect drug distribution, metabolism, excretion; or received surgery within 4 weeks before the use of study drugs; or plan to undergo surgery during the study period; -
6. Use of any drugs (including Chinese herbal medicine, health products, etc.) within 14 days before the use of the study drug;
7. Vaccination or live attenuated vaccine within 14 days before the use of the study drug, or plan to vaccinate during the trial;
8. Blood donation or massive blood loss (\> 400 mL) within 3 months before the use of the study drug, receiving blood transfusion or use of blood products, or intend to donate blood or blood components during the trial or within 3 months after the end of the trial;
9. Drug abusers or use of soft drugs (such as marijuana) or hard drugs (such as cocaine, phencyclidine, etc.) within 1 year before the use of the study drug;
10. Smokers or smokers who smoke more than 5 cigarettes per day for 3 months before the use of the study drug, or can not stop using any tobacco products during the trial;
11. habitual drinking, tea, coffee and/or caffeine-containing beverages and do not agree to stop eating the above diet during the trial;
12. special requirements for diet, can not comply with the unified diet, or lactose intolerance;
13. volunteers (or their partners) during the trial to 3 months after the end of the trial have a pregnancy plan, sperm donation and egg donation plan, or reluctant to take one or more non-drug contraceptive measures (such as complete abstinence, condoms, contraceptive rings, partner ligation, etc.);
14. female volunteers are pregnant or lactating women; or have non-protective sex within 2 weeks before the use of the study drug; or use oral contraceptives within 30 days before the use of the study drug or use of long-acting estrogen or progestogen injection or implants within 6 months before the use of the study drug; 15. physical examination, 12-lead electrocardiogram, vital signs, abdominal ultrasound, chest X-ray, laboratory tests are abnormal clinical significance (subject to the clinician 's judgment);
16\. Volunteers may not be able to complete this study for other reasons or have other reasons for not being suitable for the trial judged by the investigator; 17. First cycle admission examination vital signs abnormal clinical significance, drug screening positive, alcohol test positive or female pregnancy test abnormal clinical significance.
18 Years
45 Years
ALL
Yes
Sponsors
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Nanjing Yoko Biomedical Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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辛玉霞
Nanjing, Jiangsu, China
Countries
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Other Identifiers
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NJLBW-YK-1169
Identifier Type: -
Identifier Source: org_study_id
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