Single-dose Pharmacokinetic, Multiple-dose Tolerability and Pharmacokinetic Studies of Benapenem for Injection in Phase I Clinical Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 主要终点
- AUC(0-24) of Benapenem
研究概览
简要总结
A single-center, randomized, open-label, three-period and three-crossover trial design is adopted in the single-dose pharmacokinetic study. 12adult volunteers, are assigned to 3 groups, B1（250mg), B2 (500mg), and B3 (1000mg). Each group of subjects receive single-dose test drug at different dosages in each period.
The tolerability and pharmacokinetic studies are performed simultaneously. Two doses, 250 mg and 500 mg, are proposed for multiple-dose tolerability and pharmacokinetic studies. The subjects are divided into two groups, C1 and C2, 12 subjects in each group, half males and half females. 250 mg group is performed first. Each subject receives only one dose, intravenous drip, once daily, for 7 consecutive days
详细描述
A single-center, randomized, open-label, three-period and three-crossover trial design is adopted in the single-dose pharmacokinetic study. Twelve healthy adult volunteers, half male and female, are enrolled and randomly assigned to three groups, B1, B2, and B3. The subjects in three groups receive three doses, 250 mg, 500 mg and 1000 mg. Each group of subjects receive single-dose test drug at different dosages in each period.
A single-center, randomized, open- label, and dose escalation trial design is used in the multiple-dose tolerability and pharmacokinetic studies. The tolerability and pharmacokinetic studies are performed simultaneously. Two doses, 250 mg and 500 mg, are proposed for multiple-dose tolerability and pharmacokinetic studies. The subjects are divided into two groups, C1 and C2, 12 subjects in each group, half males and half females. 250 mg group is performed first. After completion of observation and confirming that the drug can be safely tolerated, study on 500 mg group is then performed. Each subject receives only one dose, intravenous drip, once daily, for 7 consecutive days
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female healthy subjects, aged 18 ~ 45;
- •Body weight ≥ 50 kg and body mass index 19.0 ~ 24.0 kg/m2;
- •Prior to the test, physical examination, blood routine, urine routine, liver and kidney functions, and related examinations normal, or mild abnormalities in indicators while without clinical significance as indicated by the investigator
- •Normal or mild abnormalities without clinical significance in the standard 12-lead ECG;
- •Signing informed consent form
排除标准
- •Regular smoking, alcohol abuse, and drug abuse;
- •Use of drugs with known damage to an organ within three months;
- •History of specific allergies, or history of drug allergy, especially those allergic to lactams and excipients of test drug;
- •Febrile illnesses within three days before the screening;
- •Patients with mental illness or psychotic disorder in the past;
- •Past mental and nervous system diseases (epilepsy, stroke, cerebrovascular disorder, etc.), gastrointestinal disorder (such as stomach ulcers, gastritis, etc.) or disorder of other systems (such as cardiovascular, respiratory, hematological, or endocrine system, etc.) diseases or medical history.
- •Taking any medication, including traditional Chinese medicine;
- •Having taken any medication that may affect test results within two weeks before the screening, such as antibiotics, NSAIDs, aluminum- or magnesium-containing antacids, diuretics, anticoagulants, central nervous system depressants, and any drug that may affect the drug absorption;
- •Having participated in other investigational drug trial in the preceding three months;
- •Blood donation for 360 ml or more within three months before the screening;
- •Heart rate<50 bpm or >100 bpm;
- •Systolic blood pressure < 90 mmHg or ≥ 140 mmHg, diastolic blood pressure ≥ 90 mmHg or < 60 mmHg;
- •Women who are pregnant or breastfeeding, or who may be pregnant without adopting acceptable contraception, or who have a positive result in serum pregnancy test;
- •Women who are planning to become pregnant within 6 months, or male subjects who are planning to make his spouse pregnant within 6 months;
- •HBsAg, HCV antibody, HIV antibody, and Treponema Pallidum antibody positive;
- •Urine drug-of-abuse testing positive;
- •Any other factor that makes the subject not suitable for the trial as indicated by the investigator.
研究组 & 干预措施
Banapenem B1 group
Dose in the 1st period 250mg; Dose in the 2nd period 500mg; Dose in the 3rd period 1000mg
干预措施: Banapenem (Drug)
Banapenem B2group
Dose in the 1st period 500mg; Dose in the 2nd period 1000mg; Dose in the 3rd period 250mg
干预措施: Banapenem (Drug)
Banapenem B3group
Dose in the 1st period 1000mg; Dose in the 2nd period 250mg; Dose in the 3rd period 500mg
干预措施: Banapenem (Drug)
Banapenem C1group
250mg Once daily for 7 consecutive days
干预措施: Banapenem (Drug)
Banapenem C2group
500mg Once daily for 7 consecutive days
干预措施: Banapenem (Drug)
结局指标
主要结局
AUC(0-24) of Benapenem
时间窗: Pre dose and 0.25,0.5,0.75,1,1.5, 2, 2.5, 3, 4, 6,8,12, 24,36,48 hours after Dosing
AUC(0-24) is the area under the curve from time 0 to 24 hours
Maximum observed plasma concentration (Cmax) of Benapenem
时间窗: Pre dose and 0.25,0.5,0.75,1,1.5, 2, 2.5, 3, 4, 6,8,12, 24,36,48 hours after Dosing
Maximum observed plasma concentration (Cmax) of following in healthy subjects
Time to maximum observed plasma concentration (tmax) of Benapenem
时间窗: Pre dose and 0.25,0.5,0.75,1,1.5, 2, 2.5, 3, 4, 6,8,12, 24,36,48 hours after Dosing
Time to maximum observed plasma concentration (tmax)
Time to elimination half-life (t1/2) of Benapenem
时间窗: Pre dose and 0.25,0.5,0.75,1,1.5, 2, 2.5, 3, 4, 6,8,12, 24,36,48 hours after Dosing
Time to elimination half-life (t1/2)
次要结局
- Number of subjects with clinically significant findings in vital signs(Screening and Day1, Day 2, Day4 after dosing)
- Number of subjects with clinically significant findings in laboratory parameters(Screening and Day1, Day 2, Day4 after dosing)
- Number of subjects with adverse events and serious adverse events(Screening and Day1, Day 2, Day4 after dosing)
- Number of subjects with clinically significant 12-lead ECGs(Screening and Day1, Day 2, Day4 after dosing)