A Phase 1, Double-Blind, Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of RC-01 for Injection in Healthy Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Number of participants with a treatment-related adverse event collected over the duration of the study
研究概览
简要总结
A Phase 1 study of the safety, tolerability and pharmacokinetics of a new antibiotic (RC-01). In Part 1 cohorts of healthy adults will participate in a single dose escalation study of increasing intravenous doses of RC-01. In Part 2 cohorts of healthy adults will participate in a multiple dose escalation study of increasing intravenous doses of RC-01 given either twice daily or three times daily.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subjects
- •Agrees to be available for all study visits and cooperate fully with the requirements of the study protocol, including the schedule of assessments
- •Willing and able to provide written informed consent
排除标准
- •Underlying hepatic, renal, metabolic, cardiovascular or immunologic disorders
- •Unable to cooperate fully with the requirements of the study protocol, including the schedule of assessments, or likely to be non-compliant with any study requirements
- •Women who are pregnant and/or nursing
研究组 & 干预措施
Single intravenous doses of RC-01
Single escalating doses of RC-01 from 200 mg to 1600 mg
干预措施: Single intravenous doses of RC-01 (Drug)
Single intravenous doses of placebo
Single intravenous doses of placebo to match RC-01
干预措施: Single intravenous doses of placebo (Drug)
Multiple intravenous doses of RC-01
Two or three times daily escalating intravenous doses of RC-01 for 10 days. Doses to be determined
干预措施: Multiple intravenous doses of RC-01 (Drug)
Multiple intravenous doses of placebo
Two or three times daily intravenous doses of placebo to match RC-01
干预措施: Multiple intravenous doses of placebo (Drug)
结局指标
主要结局
Number of participants with a treatment-related adverse event collected over the duration of the study
时间窗: Up to the final follow-up 1 day visit
Safety assessments will include physical examinations, vital signs including heart rate and respiratory rate, clinical laboratory tests (including hematology, serum chemistry, coagulation and urinalysis), and ECG parameters (including P-wave onset, QRS onset, QRS offset, and end of T wave)
次要结局
- Plasma concentration time data for RC-01 and metabolites(Pre-dose through 24 hours after the final infusion of study drug)
- Bioavailability of RC-01 and other RC-01 metabolites(Pre-dose through 24 hours after the final infusion of study drug)
- Elimination of RC-01 and its metabolites in the urine following single and multiple dose administration(Pre-dose through 24 hours after the final infusion of study drug)