PharmacokineticsPhase 1NCT05588531
Study on Tolerance, Pharmacokinetics and Drug Interaction of YK-1169 in Healthy Volunteers
A Phase 1 study testing Group 1:YK-1169 in people with Pharmacokinetics, run by Nanjing Yoko Biomedical Co., Ltd. at 1 site in China.
Trial summary
To evaluate the safety and tolerability of multiple doses of YK-1169 in healthy subjects, the pharmacokinetic characteristics of multiple doses in healthy subjects, and the drug interaction between cefepime and avibactam. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics
- What is being tested?
- Group 1:YK-1169
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteChina
- Study dates
- 20 Dec 2021to 8 Apr 2022
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy subjects aged 18 to 45 years (including the cut-off value), both men and women;
- body mass index (BMI) 19.0-28.0 kg/m2 (including the cut-off value);
- 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;
- be able to communicate well with the investigator, and understand and abide by the requirements of this study.
Who cannot join
- participate in any drug clinical trials or use of study drugs within 3 months before the use of study drugs;
- 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;
- 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;
- can not tolerate intravenous puncture or have a history of halo, fainting needle;
- 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; -
- Use of any drugs (including Chinese herbal medicine, health products, etc.) within 14 days before the use of the study drug;
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- Vaccination or live attenuated vaccine within 14 days before the use of the study drug, or plan to vaccinate during the trial;
- 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;
- 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;
- 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;
- habitual drinking, tea, coffee and/or caffeine-containing beverages and do not agree to stop eating the above diet during the trial;
- special requirements for diet, can not comply with the unified diet, or lactose intolerance;
- 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.);
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
To evaluate the safety and tolerability of multiple doses of YK-1169 in healthy subjects, the pharmacokinetic characteristics of multiple doses in healthy subjects, and the drug interaction between cefepime and avibactam.
Read the detailed description
A randomized, single-blind, placebo-controlled, dose-escalation, single-center clinical trial design was used. A total of 5 dose groups A1, A2, A3, A4 and A5 were set in the test, including A1 YK-1169 0.5g group (containing cefepime 0.4g and avibactam 0.1g), A2 YK-1169 1.25g group (containing cefepime 1.0g and avibactam 0.25g), A3 YK-1169 2.5g (containing cefepime 2.0g and avibactam 0.5g), A4 YK-1169 3.75g (containing cefepime 3.0g and avibactam 0.75g) and A5 YK-1169 5.0g (containing cefepime 4.0g and avibactam 1.0g).
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
- Pharmacokinetics
- Being tested
- Group 1:YK-1169, Group 2:YK-1169/Placebo Injection, Group 3:YK-1169/Placebo, Group 4:YK-1169/Placebo, Group 5:YK-1169/Placebo Injection
- Keywords
- YK-1169
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group 1:YK-1169Drug
YK-1169 0.5g (containing cefepime 0.4g, avibactam 0.1g) single intravenous infusion for 2 hours
Group 2:YK-1169/Placebo InjectionDrug
YK-1169 1.25g (containing cefepime 1.0g, avibactam 0.25g) / placebo single intravenous infusion for 2 hours
Group 3:YK-1169/PlaceboDrug
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/PlaceboDrug
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 InjectionDrug
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 injectionDrug
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
| Study group | Role | What they receive |
|---|---|---|
| YK-1169 0.5g (containing cefepime 0.4g, avibactam 0.1g) | Active comparator | Four healthy subjects in group A1, two males and two females, without control, were administered the test drug Receives: Drug: Group 1:YK-1169 |
| YK-1169 1.25 g (containing cefepime 1.0 g and avibactam 0.25 g) | Active comparator | 12 healthy subjects, of whom 10 subjects were administered the investigational product and 2 subjects were administered placebo, half males and half females Receives: Drug: Group 2:YK-1169/Placebo Injection |
| YK-1169 2.5g (containing cefepime 2.0g and avibactam 0.5g) | Active comparator | 12 healthy subjects, of whom 10 subjects were administered the investigational product and 2 subjects were administered placebo, half males and half females Receives: Drug: Group 3:YK-1169/Placebo |
| YK-1169 3.75g (containing cefepime 3.0g and avibactam 0.75g) | Placebo comparator | 12 healthy subjects, of whom 10 subjects were administered the investigational product and 2 subjects were administered placebo, half males and half females Receives: Drug: Group 4:YK-1169/Placebo |
| YK-1169 5.0g (containing cefepime 4.0g and avibactam 1.0g) | Active comparator | 8 healthy subjects, 6 of whom were administered the investigational product and 2 of whom were administered placebo, half males and half females Receives: Drug: Group 5:YK-1169/Placebo Injection |
| Drug Interaction Studies | Active comparator | 18 subjects (single gender not less than 1/3) were randomly divided into D1, D2 and D3 groups, 6 subjects for each group Receives: Drug: Group 1:YK-1169; Drug: Group 6:YK-1169/Cefepime hydrochloride for injection/Avibactam for injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
According to Common Terminology Criteria for Adverse Events Version 5.0, the incidence and frequency of AEs and SAEs will be statistically analyzed
Descriptive analysis was used to calculate the incidence of adverse events and adverse reactions, and the number and frequency of occurrence of various adverse events and adverse reactions.
Measured: Through study completion, an average of 1 month.
clinical adverse events
Descriptive analysis was used to analyze the relationship and outcome between the degree and duration of adverse events and the drug on a case-by-case basis
Measured: Through study completion, an average of 1 month.
body temperature (frontal temperature)
Abnormal body temperature (frontal temperature) and body temperature (℃) before and after administration will be analyzed on a case-by-case basis
Measured: Through study completion, an average of 1 month.
Pulse
Abnormal pulse before and after dosing will be analyzed on a case-by-case basis. Pulse (beats/min)
Measured: Through study completion, an average of 1 month.
sitting blood pressure
Abnormal blood pressure before and after dosing will be analyzed on a case-by-case basis. Blood pressure (MmHg)
Measured: Through study completion, an average of 1 month.
physical examination
Abnormalities before and after administration of physical examination were analyzed on a case-by-case basis
Measured: Through study completion, an average of 1 month.
laboratory tests
Abnormalities before and after administration in laboratory tests were analyzed on a case-by-case basis
Measured: Through study completion, an average of 1 month.
12-lead ECG
Abnormalities before and after 12-lead ECG administration were analyzed on a case-by-case basis
Measured: Through study completion, an average of 1 month.
premature withdrawal
Analysis of early withdrawals on a case-by-case basis
Measured: Through study completion, an average of 1 month.
Secondary outcomes (14)
The main pharmacokinetic parameters evaluated in the single-dose and drug-drug interaction studies included: Cmax
Pharmacokinetic parameters were calculated using WinNonlin 8.2 (or higher) software from Certara, USA. The main pharmacokinetic parameters evaluated in the single-dose and drug-drug interaction studies included: Cmax
Measured: Single dose: within 1 hour before to 24 hours after dosing on Day 1.Drug Interactions: Within 1 hour prior to dosing on Day 1 through 24 hours postdose of each cycle
The main pharmacokinetic parameters evaluated in the single-dose and drug-drug interaction studies included: Tmax
Pharmacokinetic parameters were calculated using WinNonlin 8.2 (or higher) software from Certara, USA. The main pharmacokinetic parameters evaluated in the single-dose and drug-drug interaction studies included: Tmax
Measured: Single dose: within 1 hour before to 24 hours after dosing on Day 1.Drug Interactions: Within 1 hour prior to dosing on Day 1 through 24 hours postdose of each cycle
The main pharmacokinetic parameters evaluated in the single-dose and drug-drug interaction studies included: AUC
Pharmacokinetic parameters were calculated using WinNonlin 8.2 (or higher) software from Certara, USA. The main pharmacokinetic parameters evaluated in the single-dose and drug-drug interaction studies included: AUC
Measured: Single dose: within 1 hour before to 24 hours after dosing on Day 1.Drug Interactions: Within 1 hour prior to dosing on Day 1 through 24 hours postdose of each cycle
The main pharmacokinetic parameters evaluated in the single-dose and drug-drug interaction studies included: t1/2
Pharmacokinetic parameters were calculated using WinNonlin 8.2 (or higher) software from Certara, USA. The main pharmacokinetic parameters evaluated in the single-dose and drug-drug interaction studies included: t1/2
Measured: Single dose: within 1 hour before to 24 hours after dosing on Day 1.Drug Interactions: Within 1 hour prior to dosing on Day 1 through 24 hours postdose of each cycle
The main pharmacokinetic parameters evaluated in the single-dose and drug-drug interaction studies included: CL
Pharmacokinetic parameters were calculated using WinNonlin 8.2 (or higher) software from Certara, USA. The main pharmacokinetic parameters evaluated in the single-dose and drug-drug interaction studies included: CL
Measured: Single dose: within 1 hour before to 24 hours after dosing on Day 1.Drug Interactions: Within 1 hour prior to dosing on Day 1 through 24 hours postdose of each cycle
The main pharmacokinetic parameters evaluated in the single-dose and drug-drug interaction studies included: VZ
Pharmacokinetic parameters were calculated using WinNonlin 8.2 (or higher) software from Certara, USA. The main pharmacokinetic parameters evaluated in the single-dose and drug-drug interaction studies included: VZ
Measured: Single dose: within 1 hour before to 24 hours after dosing on Day 1.Drug Interactions: Within 1 hour prior to dosing on Day 1 through 24 hours postdose of each cycle
The main pharmacokinetic parameters evaluated in the single-dose and drug-drug interaction studies included: λz
Pharmacokinetic parameters were calculated using WinNonlin 8.2 (or higher) software from Certara, USA. The main pharmacokinetic parameters evaluated in the single-dose and drug-drug interaction studies included: λz
Measured: Single dose: within 1 hour before to 24 hours after dosing on Day 1.Drug Interactions: Within 1 hour prior to dosing on Day 1 through 24 hours postdose of each cycle
Cumulative urinary excretion ratio, etc. in 2.5 g single dose group of YK-1169
Pharmacokinetic parameters were calculated using WinNonlin 8.2 (or higher) software from Certara, USA. Calculated cumulative urinary excretion ratio, etc. for 2.5 g single dose of YK-1169
Measured: Single dose: within 1 hour before to 24 hours after dosing on Day 1
Main pharmacokinetic parameters evaluated in multiple dose studies included: C min, ss
Main pharmacokinetic parameters evaluated in multiple dose studies included: C min, ss
Measured: Multiple dose: within 1 hour before dosing on Day 1 to D9 (24 hours after dosing on D8).
Main pharmacokinetic parameters evaluated in multiple dose studies included: C max,ss
Main pharmacokinetic parameters evaluated in multiple dose studies included: C max,ss
Measured: Multiple dose: within 1 hour before dosing on Day 1 to D9 (24 hours after dosing on D8).
Main pharmacokinetic parameters evaluated in multiple dose studies included: Tmax,ss
Main pharmacokinetic parameters evaluated in multiple dose studies included: Tmax,ss
Measured: Multiple dose: within 1 hour before dosing on Day 1 to D9 (24 hours after dosing on D8).
Main pharmacokinetic parameters evaluated in multiple dose studies included:AUC
Main pharmacokinetic parameters evaluated in multiple dose studies included:AUC
Measured: Multiple dose: within 1 hour before dosing on Day 1 to D9 (24 hours after dosing on D8).
Main pharmacokinetic parameters evaluated in multiple dose studies included:Cav,ss
Main pharmacokinetic parameters evaluated in multiple dose studies included:Cav,ss
Measured: Multiple dose: within 1 hour before dosing on Day 1 to D9 (24 hours after dosing on D8).
Main pharmacokinetic parameters evaluated in multiple dose studies included:t1/2
Main pharmacokinetic parameters evaluated in multiple dose studies included:t1/2
Measured: Multiple dose: within 1 hour before dosing on Day 1 to D9 (24 hours after dosing on D8).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2022
- Study start20 Dec 2021
- Primary completion2 Apr 2022
- Study completion8 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacokineticsStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- The whole trial is conducted by dose escalation from low to high.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanjing Yoko Biomedical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05588531
- Sponsor's protocol ID
- NJLBW-YK-1169
- Status last verified
- Oct 2022
- First submitted
- 19 Aug 2022
- Last updated
- 20 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Tolerance, Pharmacokinetics and Drug Interaction of YK-1169 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05588531
- Acronym / sponsor ID
- NJLBW-YK-1169
- Conditions
- Pharmacokinetics
- Keywords
- YK-1169
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Nanjing Yoko Biomedical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Dec 2021 (actual)
- Primary completion
- 2 Apr 2022 (actual)
- Study completion
- 8 Apr 2022 (actual)
- First posted
- 20 Oct 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.
To evaluate the safety and tolerability of multiple doses of YK-1169 in healthy subjects, the pharmacokinetic characteristics of multiple doses in healthy subjects, and the drug interaction between cefepime and avibactam.
Detailed description
A randomized, single-blind, placebo-controlled, dose-escalation, single-center clinical trial design was used. A total of 5 dose groups A1, A2, A3, A4 and A5 were set in the test, including A1 YK-1169 0.5g group (containing cefepime 0.4g and avibactam 0.1g), A2 YK-1169 1.25g group (containing cefepime 1.0g and avibactam 0.25g), A3 YK-1169 2.5g (containing cefepime 2.0g and avibactam 0.5g), A4 YK-1169 3.75g (containing cefepime 3.0g and avibactam 0.75g) and A5 YK-1169 5.0g (containing cefepime 4.0g and avibactam 1.0g).
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 6
- Model description
- The whole trial is conducted by dose escalation from low to high.
| Arm | Type | Receives |
|---|---|---|
| YK-1169 0.5g (containing cefepime 0.4g, avibactam 0.1g) | Active comparator | Drug: Group 1:YK-1169Four healthy subjects in group A1, two males and two females, without control, were administered the test drug |
| YK-1169 1.25 g (containing cefepime 1.0 g and avibactam 0.25 g) | Active comparator | Drug: Group 2:YK-1169/Placebo Injection12 healthy subjects, of whom 10 subjects were administered the investigational product and 2 subjects were administered placebo, half males and half females |
| YK-1169 2.5g (containing cefepime 2.0g and avibactam 0.5g) | Active comparator | Drug: Group 3:YK-1169/Placebo12 healthy subjects, of whom 10 subjects were administered the investigational product and 2 subjects were administered placebo, half males and half females |
| YK-1169 3.75g (containing cefepime 3.0g and avibactam 0.75g) | Placebo comparator | Drug: Group 4:YK-1169/Placebo12 healthy subjects, of whom 10 subjects were administered the investigational product and 2 subjects were administered placebo, half males and half females |
| YK-1169 5.0g (containing cefepime 4.0g and avibactam 1.0g) | Active comparator | Drug: Group 5:YK-1169/Placebo Injection8 healthy subjects, 6 of whom were administered the investigational product and 2 of whom were administered placebo, half males and half females |
| Drug Interaction Studies | Active comparator | Drug: Group 1:YK-1169, Drug: Group 6:YK-1169/Cefepime hydrochloride for injection/Avibactam for injection18 subjects (single gender not less than 1/3) were randomly divided into D1, D2 and D3 groups, 6 subjects for each group |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- healthy subjects aged 18 to 45 years (including the cut-off value), both men and women;
- body mass index (BMI) 19.0-28.0 kg/m2 (including the cut-off value);
- 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;
- be able to communicate well with the investigator, and understand and abide by the requirements of this study.
Key exclusion criteria (15 listed)
- participate in any drug clinical trials or use of study drugs within 3 months before the use of study drugs;
- 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;
- 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;
- can not tolerate intravenous puncture or have a history of halo, fainting needle;
- 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; -
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 |
|---|---|---|
| Group 1:YK-1169YK-1169 0.5g (containing cefepime 0.4g, avibactam 0.1g) single intravenous infusion for 2 hours | Drug | Drug Interaction Studies, YK-1169 0.5g (containing cefepime 0.4g, avibactam 0.1g) |
| Group 2:YK-1169/Placebo InjectionYK-1169 1.25g (containing cefepime 1.0g, avibactam 0.25g) / placebo single intravenous infusion for 2 hours | Drug | YK-1169 1.25 g (containing cefepime 1.0 g and avibactam 0.25 g) |
| Group 3:YK-1169/PlaceboOn 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 | Drug | YK-1169 2.5g (containing cefepime 2.0g and avibactam 0.5g) |
| Group 4:YK-1169/PlaceboOn 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 | Drug | YK-1169 3.75g (containing cefepime 3.0g and avibactam 0.75g) |
| Group 5:YK-1169/Placebo InjectionYK-1169 5.0g (containing cefepime 4.0g, avibactam 1.0g) / placebo single intravenous infusion for 2 hours | Drug | YK-1169 5.0g (containing cefepime 4.0g and avibactam 1.0g) |
| Group 6:YK-1169/Cefepime hydrochloride for injection/Avibactam for injectionYK-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 | Drug | Drug Interaction Studies |
Primary outcome
According to Common Terminology Criteria for Adverse Events Version 5.0, the incidence and frequency of AEs and SAEs will be statistically analyzed
Time frame: Through study completion, an average of 1 month.
Descriptive analysis was used to calculate the incidence of adverse events and adverse reactions, and the number and frequency of occurrence of various adverse events and adverse reactions.
clinical adverse events
Time frame: Through study completion, an average of 1 month.
Descriptive analysis was used to analyze the relationship and outcome between the degree and duration of adverse events and the drug on a case-by-case basis
body temperature (frontal temperature)
Time frame: Through study completion, an average of 1 month.
Abnormal body temperature (frontal temperature) and body temperature (℃) before and after administration will be analyzed on a case-by-case basis
Pulse
Time frame: Through study completion, an average of 1 month.
Abnormal pulse before and after dosing will be analyzed on a case-by-case basis. Pulse (beats/min)
sitting blood pressure
Time frame: Through study completion, an average of 1 month.
Abnormal blood pressure before and after dosing will be analyzed on a case-by-case basis. Blood pressure (MmHg)
physical examination
Time frame: Through study completion, an average of 1 month.
Abnormalities before and after administration of physical examination were analyzed on a case-by-case basis
laboratory tests
Time frame: Through study completion, an average of 1 month.
Abnormalities before and after administration in laboratory tests were analyzed on a case-by-case basis
12-lead ECG
Time frame: Through study completion, an average of 1 month.
Abnormalities before and after 12-lead ECG administration were analyzed on a case-by-case basis
premature withdrawal
Time frame: Through study completion, an average of 1 month.
Analysis of early withdrawals on a case-by-case basis
14 secondary outcomes
The main pharmacokinetic parameters evaluated in the single-dose and drug-drug interaction studies included: Cmax
Time frame: Single dose: within 1 hour before to 24 hours after dosing on Day 1.Drug Interactions: Within 1 hour prior to dosing on Day 1 through 24 hours postdose of each cycle
The main pharmacokinetic parameters evaluated in the single-dose and drug-drug interaction studies included: Tmax
Time frame: Single dose: within 1 hour before to 24 hours after dosing on Day 1.Drug Interactions: Within 1 hour prior to dosing on Day 1 through 24 hours postdose of each cycle
The main pharmacokinetic parameters evaluated in the single-dose and drug-drug interaction studies included: AUC
Time frame: Single dose: within 1 hour before to 24 hours after dosing on Day 1.Drug Interactions: Within 1 hour prior to dosing on Day 1 through 24 hours postdose of each cycle
The main pharmacokinetic parameters evaluated in the single-dose and drug-drug interaction studies included: t1/2
Time frame: Single dose: within 1 hour before to 24 hours after dosing on Day 1.Drug Interactions: Within 1 hour prior to dosing on Day 1 through 24 hours postdose of each cycle
The main pharmacokinetic parameters evaluated in the single-dose and drug-drug interaction studies included: CL
Time frame: Single dose: within 1 hour before to 24 hours after dosing on Day 1.Drug Interactions: Within 1 hour prior to dosing on Day 1 through 24 hours postdose of each cycle
The main pharmacokinetic parameters evaluated in the single-dose and drug-drug interaction studies included: VZ
Time frame: Single dose: within 1 hour before to 24 hours after dosing on Day 1.Drug Interactions: Within 1 hour prior to dosing on Day 1 through 24 hours postdose of each cycle
The main pharmacokinetic parameters evaluated in the single-dose and drug-drug interaction studies included: λz
Time frame: Single dose: within 1 hour before to 24 hours after dosing on Day 1.Drug Interactions: Within 1 hour prior to dosing on Day 1 through 24 hours postdose of each cycle
Cumulative urinary excretion ratio, etc. in 2.5 g single dose group of YK-1169
Time frame: Single dose: within 1 hour before to 24 hours after dosing on Day 1
Main pharmacokinetic parameters evaluated in multiple dose studies included: C min, ss
Time frame: Multiple dose: within 1 hour before dosing on Day 1 to D9 (24 hours after dosing on D8).
Main pharmacokinetic parameters evaluated in multiple dose studies included: C max,ss
Time frame: Multiple dose: within 1 hour before dosing on Day 1 to D9 (24 hours after dosing on D8).
Main pharmacokinetic parameters evaluated in multiple dose studies included: Tmax,ss
Time frame: Multiple dose: within 1 hour before dosing on Day 1 to D9 (24 hours after dosing on D8).
Main pharmacokinetic parameters evaluated in multiple dose studies included:AUC
Time frame: Multiple dose: within 1 hour before dosing on Day 1 to D9 (24 hours after dosing on D8).
Main pharmacokinetic parameters evaluated in multiple dose studies included:Cav,ss
Time frame: Multiple dose: within 1 hour before dosing on Day 1 to D9 (24 hours after dosing on D8).
Main pharmacokinetic parameters evaluated in multiple dose studies included:t1/2
Time frame: Multiple dose: within 1 hour before dosing on Day 1 to D9 (24 hours after dosing on D8).
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 20 Oct 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.
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 Group 1:YK-1169 in people with Pharmacokinetics, run by Nanjing Yoko Biomedical 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 4 inclusion and 15 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 20 Oct 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?
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?
According to Common Terminology Criteria for Adverse Events Version 5.0, the incidence and frequency of AEs and SAEs will be statistically analyzed (time frame: Through study completion, an average of 1 month.). 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 20 Oct 2022.