Phase I, Single and Multiple Ascending Dose Study to Investigate the Safety, Tolerability and Pharmacokinetics of AAI101 Administered Intravenously Alone or in Combination With Piperacillin or Cefepime to Healthy Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 主要终点
- Safety Profile - Number of Subjects With at Least one Adverse Event
研究概览
简要总结
- To assess the safety and tolerability of single and multiple ascending intravenous doses of AAI101 (SAD & MAD) in healthy male subjects.
- To assess the safety and tolerability of single and multiple ascending intravenous doses of AAI101 in combination with fixed intravenous doses of piperacillin or cefepime in healthy male subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male healthy volunteers aged between 18 and 45 years (inclusive) at screening.
- •Body mass index (BMI) of 18.0 to 30.0 Kg/m2 (inclusive) at screening.
- •Healthy as determined by the investigator on the basis of medical history, physical examination findings, clinical laboratory test results, vital sign measurements, and digital 12 lead ECG readings (all results were to be within normal range or considered non-clinically significant by the investigator).
- •Non-smoker or smoker of fewer than 10 cigarettes per day as determined by medical history. Had to be able to abstain from smoking during the inpatient stay.
- •Ability to communicate well with the investigator in the local language, and to understand and comply with the requirements of the study.
排除标准
- •Any significant cardiovascular (e.g., hypertension), hepatic, renal, respiratory (e.g., childhood asthma), gastrointestinal, endocrine (e.g., diabetes, dyslipidemia), immunologic, hematological, neurologic, or psychiatric disease.
- •Acute disease state (e.g., nausea, vomiting, fever, diarrhea) within 7 days before study Day 1.
研究组 & 干预措施
0.9% saline infusion
Saline 0.9% infusion
干预措施: AAI101 i.v. (Drug)
0.9% saline infusion
Saline 0.9% infusion
干预措施: Saline 0.9% infusion (Drug)
AAI101 i.v.
600 mg, 1g, 2g, 4g, 1g q6h, 2g q6h.
Drug-Drug Interaction:
Sequence 1 = piperacillin 4 g i.v. - AAI101 2 g i.v. - AAI101 2 g + piperacillin 4 g i.v. - cefepime 2 g i.v. - AAI101 2 g + cefepime 2 g i.v.
Sequence 2 = cefepime 2 g i.v. - piperacillin 4 g i.v. - AAI101 2 g + cefepime 2 g i.v. - AAI101 2 g i.v. - AAI101 2 g + piperacillin 4 g i.v.
干预措施: AAI101 i.v. (Drug)
AAI101 i.v.
600 mg, 1g, 2g, 4g, 1g q6h, 2g q6h.
Drug-Drug Interaction:
Sequence 1 = piperacillin 4 g i.v. - AAI101 2 g i.v. - AAI101 2 g + piperacillin 4 g i.v. - cefepime 2 g i.v. - AAI101 2 g + cefepime 2 g i.v.
Sequence 2 = cefepime 2 g i.v. - piperacillin 4 g i.v. - AAI101 2 g + cefepime 2 g i.v. - AAI101 2 g i.v. - AAI101 2 g + piperacillin 4 g i.v.
干预措施: Saline 0.9% infusion (Drug)
Piperacillin i.v.
Piperacillin 3 g
干预措施: Piperacillin i.v. (Drug)
Cefepime i.v.
Cefepime 1 g
干预措施: Cefepime i.v. (Drug)
结局指标
主要结局
Safety Profile - Number of Subjects With at Least one Adverse Event
时间窗: Throughout the period that subjects receive study drug up to 5 days following discontinuation of study treatment
Safety will be evaluated from reported signs and symptoms and clinical laboratory tests
次要结局
- AAI101 maximum plasma concentration (Cmax)(Up to 24 hours post-dose)
- AAI101 Clast(Up to 24 hours post-dose)
- AAI101 AUC(0-t) - AUC(0-8)(Up to 24 hours post-dose)
- AAI101 half life (t1/2)(Up to 24 hours post-dose)