A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Incidence of Hypersensitivity After Repeated Single Dose Administrations of Sugammadex (SCH 900616) in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 448
- 主要终点
- The Percentage of Participants With Adjudicated Hypersensitivity Signs/Symptoms, for Each Sugammadex Dose Group and Placebo.
研究概览
简要总结
This trial was conducted to study the potential for hypersensitivity symptoms at the time of initial exposure to sugammadex and upon repeat exposure, since it was unknown whether the frequency or severity of hypersensitivity symptoms may worsen at repeat exposure over a prolonged period.
In total 450 participants (all healthy subjects) were to be randomized to receive one of three study treatments: three repeated doses of either sugammadex 4 mg/kg, sugammadex 16 mg/kg, or placebo. Participants were to receive one dose of study treatment on Day 8, Day 36, and Day 78 of the study in order to determine the safety of each treatment dose.
详细描述
All subjects were to be admitted to the study center the day before each scheduled dose and were to leave the unit the morning of the day after each dose. In cases of suspected hypersensitivity symptoms, healthy subjects were to remain confined to the study center until all signs and symptoms regressed, the subject was stable, and the investigator considered it safe for the subject to leave the study center. Four sites participated in this trial.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18-55 years of age
- •Serum tryptase <=11.4 mcg/L and fasting triglyceride levels within normal limits
- •Safety laboratory tests and vital signs must have been within normal limits
- •Screening electrocardiogram must have been clinically acceptable and parameters within normal limits
- •Body Mass Index between 19 and 32 kg/m^2
- •Females must have agreed to use contraceptives
- •Other certain administrative criteria as described in the protocol
排除标准
- •Females who were pregnant or intending to become pregnant
- •Subjects who would not be able to participate optimally in the study, in the opinion of the investigator
- •Certain surgical or medical conditions, recent infections, or mental instability
- •Positive test for certain drugs or history of alcohol or drug abuse
- •Positive test for hepatitis B, hepatitis C, or Human Immunodeficiency Virus (HIV)
- •Blood donation in the past 60 days
- •A history of unexplained reaction or hypersensitivity reaction during previous surgery and/or anesthesia
- •History of anaphylaxis from any cause, suspected history of hypersensitivity to cyclodextrins, or multiple drug hypersensitivities
- •Heavy smoker
- •Received certain medications in the past
- •History of allergy, hypersensitivity, or intolerance to epinephrine at greater risk of developing adverse reactions after epinephrine administration
- •Other certain administrative criteria as described in the protocol
研究组 & 干预措施
Sugammadex 4 mg/kg
Participants were to receive one dose of sugammadex 4 mg/kg intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.
干预措施: Placebo run-in dose (Drug)
Sugammadex 4 mg/kg
Participants were to receive one dose of sugammadex 4 mg/kg intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.
干预措施: Sugammadex 4 mg/kg (Drug)
Sugammadex 16 mg/kg
Participants were to receive one dose of sugammadex 16 mg/kg intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.
干预措施: Placebo run-in dose (Drug)
Sugammadex 16 mg/kg
Participants were to receive one dose of sugammadex 16 mg/kg intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.
干预措施: Sugammadex 16 mg/kg (Drug)
Placebo
Participants were to receive one dose of placebo intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.
干预措施: Placebo run-in dose (Drug)
Placebo
Participants were to receive one dose of placebo intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.
干预措施: Placebo (Drug)
结局指标
主要结局
The Percentage of Participants With Adjudicated Hypersensitivity Signs/Symptoms, for Each Sugammadex Dose Group and Placebo.
时间窗: Day 8, Day 36, and Day 78 of the study
Hypersensitivity signs/symptoms were systematically collected for each subject by the investigator. Suspected cases of hypersensitivity signs/symptoms were sent to the independent Adjudication Committee (comprised of anesthesiologists \& allergists/immunologists) for blinded review and determination of adjudicated hypersensitivity \&/or anaphylaxis based on expert evaluation of all clinical data from the healthy subject. The percentages of subjects who had adjudicated hypersensitivity at any dose (dose 1/Day 8, dose 2/Day 36, or dose 3/Day 78) were compared between the 3 treatment groups.
次要结局
- The Percentage of Participants With Adjudicated Anaphylaxis According to the Definition by Sampson et al., for Each Sugammadex Dose Group and Placebo.(Day 8, Day 36, and Day 78 of the study)
- The Percentage of Participants With Each of the 3 Levels of Diagnostic Certainty of Adjudicated Anaphylaxis According to the Definition by Rüggeberg et al., for Each Sugammadex Dose Group and Placebo.(Day 8, Day 36, and Day 78 of the study)
- The Percentage of Participants With Adjudicated Hypersensitivity Signs/Symptoms After Each Randomized Dose of Study Treatment, for Each Sugammadex Dose Group and Placebo.(Day 8, Day 36, and Day 78 of the study)