Phase I Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of WCK 5107 Alone and in Combination With Cefepime Administered as Single IV Doses in Healthy Human Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Wockhardt
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Safety - number of adverse events .
研究概览
简要总结
• To evaluate the safety,tolerability and pharmacokinetics of single intravenous doses of WCK 5107 alone and in combination with cefepime in healthy adult human subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female, 18-55 years of age (both inclusive).
- •Have a body mass index of 18-30 kg/m2 (both inclusive) calculated as weight (kg)/height (m2).
- •Medical history without any major pathology/surgery in the last 6 months prior to screening.
- •Resting supine blood pressure of 90-139 (systolic)/40-89 (diastolic) mmHg and a resting pulse rate of 40-100 beats per minute.
- •Calculated creatinine clearance ≥80 mL/min
- •Computerized 12-lead ECG recording without signs of clinically significant pathology and showing no clinically significant deviation as judged by the Principal Investigator.
- •Males willing to use double-barrier contraceptive measures and to not donate sperm until 90 days after the follow-up visit.
- •Females should not be pregnant or breast feeding (pregnancy will be confirmed by a urine pregnancy test at screening with confirmation by a serum pregnancy test at admission) or of non-childbearing potential at screening.
- •Females must be either post-menopausal for at least 1 year, surgically sterile (bilateral oophorectomy or hysterectomy), or practicing 1 of the acceptable methods of birth control.
排除标准
- •History/evidence of clinically relevant pathology.
- •History of clinically significant food or drug allergy, including known hypersensitivity to cefepime or any other related drugs.
- •A positive screen result for drugs of abuse/alcohol at admission to the study center.
- •Use of prescription medications (with the exception of oral contraceptives and hormone replacement therapy) including nonsteroidal anti-inflammatory drugs or sucralfate or herbal preparations.
- •Positive screen result for hepatitis B, hepatitis C, or human immunodeficiency virus at screening.
- •Any strenuous activity within 4 days prior to admission to the study center. Strenuous being defined as any hard labor or exercise outside of a subject's usual behavior.
- •History of blood donation of more than 500 mL in the last 2 months prior to screening.
- •Current use or has used tobacco- or nicotine-containing products.
研究组 & 干预措施
WCK 5107
A single administration of the investigational product will be administered intravenously in 7 SAD cohorts at different dose level . The SAD cohorts will enroll 10 subjects ( 8 on active drug and 2 on placebo)
干预措施: WCK 5107 250 mg to 2000 mg (Drug)
WCK 5107
A single administration of the investigational product will be administered intravenously in 7 SAD cohorts at different dose level . The SAD cohorts will enroll 10 subjects ( 8 on active drug and 2 on placebo)
干预措施: Placebo (Drug)
WCK 5107 1000 mg and Cefepime 2000 mg
In the crossover cohorts (WCK 5107 and cefepime, both alone and in combination), 9 subjects will receive all 3 treatments.
干预措施: WCK 5107 250 mg to 2000 mg (Drug)
WCK 5107 1000 mg and Cefepime 2000 mg
In the crossover cohorts (WCK 5107 and cefepime, both alone and in combination), 9 subjects will receive all 3 treatments.
干预措施: Cefepime 2000 mg (Drug)
WCK 5107 1000 mg and Cefepime 2000 mg
In the crossover cohorts (WCK 5107 and cefepime, both alone and in combination), 9 subjects will receive all 3 treatments.
干预措施: WCK 5107 1000/2000 mg with Cefepime 2000 mg combination (Drug)
WCK 5107 2000 mg and Cefepime 2000 mg
In the crossover cohorts (WCK 5107 and cefepime, both alone and in combination), 9 subjects will receive all 3 treatments.
干预措施: WCK 5107 250 mg to 2000 mg (Drug)
WCK 5107 2000 mg and Cefepime 2000 mg
In the crossover cohorts (WCK 5107 and cefepime, both alone and in combination), 9 subjects will receive all 3 treatments.
干预措施: Cefepime 2000 mg (Drug)
WCK 5107 2000 mg and Cefepime 2000 mg
In the crossover cohorts (WCK 5107 and cefepime, both alone and in combination), 9 subjects will receive all 3 treatments.
干预措施: WCK 5107 1000/2000 mg with Cefepime 2000 mg combination (Drug)
结局指标
主要结局
Safety - number of adverse events .
时间窗: 14 days
To evaluate the safety of single intravenous doses of WCK 5107 alone and in combination with cefepime in healthy adult human subjects.
Tolerability-measure of laboratory parameters
时间窗: 14 days
To evaluate the tolerability of single intravenous doses of WCK
次要结局
- PK- Cmax(3 days)
- PK-time to Cmax(3 days)
- PK-AUC(3 days)