INcreased Flow Utilizing Subcutaneously-Enabled Ceftriaxone (INFUSE-Ceftriaxone) Study: A Phase I Study Comparing the Safety and Pharmacokinetics of Ceftriaxone Administered Subcutaneously With and Without Human Recombinant Hyaluronidase (HYLENEX Recombinant) and Intravenously in Human Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 主要终点
- AUC0-t
研究概览
简要总结
The objectives of this study are:
- to establish the safety of subcutaneous administration of ceftriaxone at different concentrations, with and without HYLENEX recombinant, and to determine the maximum tolerated concentration;
- and to establish the pharmacokinetic comparability of subcutaneous administration of ceftriaxone with HYLENEX recombinant to subcutaneous administration without HYLENEX recombinant and to IV administration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female, 18-65 years of age
- •If female: non-lactating; non-pregnant; and incapable of becoming pregnant, or taking specific precautions to avoid becoming pregnant before and during study
- •Normal clinical laboratory parameters
- •Adequate venous access in both upper extremities
- •Agreeing to refrain from smoking and from ingesting any alcohol or caffeine-containing products before and during the study
- •Good health based on medical history, physical examination and laboratory tests
- •Non-smoking; or smoking less than 10 cigarettes per day and willing to refrain from use of nicotine products before and during study
排除标准
- •Received a cephalosporin within the 21 days prior to study or anticipated to receive non-study cephalosporin during study
- •Pregnant or breast-feeding.
- •Previously exposed to a hyaluronidase drug product
- •Medical condition presenting unacceptable safety risk or likely to prevent completion of study
- •Known hypersensitivity to hyaluronidase or any other ingredient in HYLENEX recombinant
- •Contraindication to ceftriaxone, including known allergy to beta-lactam antibiotics
- •Local condition precluding subcutaneous injection or injection site evaluation
- •History of gastrointestinal disease (in particular colitis)
- •Consumption of caffeine- or other methylxanthine-containing beverage within 24 hours before and/or during the PK sampling period
- •Participation in study of any investigational drug or device within 30 days before this study
- •Serum hemoglobin <12 g/dL.
- •Blood donation or significant loss of blood within 56 days, or plasma donation within 7 days, prior to study
- •Medical history/condition, screening physical examination finding or clinical laboratory result precluding safe participation in study, or which might adversely effect interpretation of study results
- •History of drug or alcohol abuse within 2 years prior to study
研究组 & 干预措施
HYLENEX SC, Placebo SC, IV
subcutaneous HYLENEX and ceftriaxone as 1st intervention, subcutaneous placebo and ceftriaxone as 2nd intervention, IV ceftriaxone as 3rd intervention
干预措施: IV Ceftriaxone (Drug)
HYLENEX SC, IV, Placebo SC
subcutaneous HYLENEX and ceftriaxone as 1st intervention, IV ceftriaxone as 2nd intervention, subcutaneous placebo and ceftriaxone as 3rd intervention
干预措施: IV Ceftriaxone (Drug)
Placebo SC, IV, HYLENEX SC
subcutaneous placebo and ceftriaxone as 1st intervention, IV ceftriaxone as 2nd intervention, subcutaneous HYLENEX and ceftriaxone as 3rd intervention
干预措施: IV Ceftriaxone (Drug)
IV, Placebo SC, HYLENEX SC
IV ceftriaxone as 1st intervention, subcutaneous placebo and ceftriaxone as 2nd intervention, subcutaneous HYLENEX and ceftriaxone as 3rd intervention
干预措施: IV Ceftriaxone (Drug)
HYLENEX SC, IV, Placebo SC
subcutaneous HYLENEX and ceftriaxone as 1st intervention, IV ceftriaxone as 2nd intervention, subcutaneous placebo and ceftriaxone as 3rd intervention
干预措施: SC Placebo and Ceftriaxone (Drug)
HYLENEX SC, Placebo SC, IV
subcutaneous HYLENEX and ceftriaxone as 1st intervention, subcutaneous placebo and ceftriaxone as 2nd intervention, IV ceftriaxone as 3rd intervention
干预措施: SC HYLENEX and Ceftriaxone (Drug)
HYLENEX SC, Placebo SC, IV
subcutaneous HYLENEX and ceftriaxone as 1st intervention, subcutaneous placebo and ceftriaxone as 2nd intervention, IV ceftriaxone as 3rd intervention
干预措施: SC Placebo and Ceftriaxone (Drug)
HYLENEX SC, IV, Placebo SC
subcutaneous HYLENEX and ceftriaxone as 1st intervention, IV ceftriaxone as 2nd intervention, subcutaneous placebo and ceftriaxone as 3rd intervention
干预措施: SC HYLENEX and Ceftriaxone (Drug)
Placebo SC, HYLENEX SC, IV
subcutaneous placebo and ceftriaxone as 1st intervention, subcutaneous HYLENEX and ceftriaxone as 2nd intervention, IV ceftriaxone as 3rd intervention
干预措施: SC HYLENEX and Ceftriaxone (Drug)
Placebo SC, HYLENEX SC, IV
subcutaneous placebo and ceftriaxone as 1st intervention, subcutaneous HYLENEX and ceftriaxone as 2nd intervention, IV ceftriaxone as 3rd intervention
干预措施: SC Placebo and Ceftriaxone (Drug)
Placebo SC, IV, HYLENEX SC
subcutaneous placebo and ceftriaxone as 1st intervention, IV ceftriaxone as 2nd intervention, subcutaneous HYLENEX and ceftriaxone as 3rd intervention
干预措施: SC HYLENEX and Ceftriaxone (Drug)
Placebo SC, IV, HYLENEX SC
subcutaneous placebo and ceftriaxone as 1st intervention, IV ceftriaxone as 2nd intervention, subcutaneous HYLENEX and ceftriaxone as 3rd intervention
干预措施: SC Placebo and Ceftriaxone (Drug)
IV, HYLENEX SC, Placebo SC
IV ceftriaxone as 1st intervention, subcutaneous HYLENEX and ceftriaxone as 2nd intervention, subcutaneous placebo and ceftriaxone as 3rd intervention
干预措施: SC HYLENEX and Ceftriaxone (Drug)
IV, HYLENEX SC, Placebo SC
IV ceftriaxone as 1st intervention, subcutaneous HYLENEX and ceftriaxone as 2nd intervention, subcutaneous placebo and ceftriaxone as 3rd intervention
干预措施: SC Placebo and Ceftriaxone (Drug)
IV, Placebo SC, HYLENEX SC
IV ceftriaxone as 1st intervention, subcutaneous placebo and ceftriaxone as 2nd intervention, subcutaneous HYLENEX and ceftriaxone as 3rd intervention
干预措施: SC HYLENEX and Ceftriaxone (Drug)
IV, Placebo SC, HYLENEX SC
IV ceftriaxone as 1st intervention, subcutaneous placebo and ceftriaxone as 2nd intervention, subcutaneous HYLENEX and ceftriaxone as 3rd intervention
干预措施: SC Placebo and Ceftriaxone (Drug)
IV, HYLENEX SC, Placebo SC
IV ceftriaxone as 1st intervention, subcutaneous HYLENEX and ceftriaxone as 2nd intervention, subcutaneous placebo and ceftriaxone as 3rd intervention
干预措施: IV Ceftriaxone (Drug)
Placebo SC, HYLENEX SC, IV
subcutaneous placebo and ceftriaxone as 1st intervention, subcutaneous HYLENEX and ceftriaxone as 2nd intervention, IV ceftriaxone as 3rd intervention
干预措施: IV Ceftriaxone (Drug)
结局指标
主要结局
AUC0-t
时间窗: Start of ceftriaxone administration through time of last measureable plasma ceftriaxone concentration
Area under the drug concentration-time curve from time zero to the time of the last measurable concentration (calculated by the linear trapezoidal method)
AUC0-inf
时间窗: from the start of ceftriaxone administration to infinity
Area under the drug concentration-time curve from time zero to infinity, calculated as AUC0-t + Ct/kel (Ct = time of last measurable concentration; kel = terminal elimination rate constant)
次要结局
- Cmax(at the time of the highest measured plasma ceftriaxone concentration)
- Tmax(from start of ceftriaxone administration until time of maximum measured plasma ceftriaxone concentration)