Conditions: Hypersensitivity
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 448
Healthy volunteers: yes

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: 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. arm 2: 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. arm 3: Participants were to receive one dose of placebo intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.

Interventions: intervention 1: Placebo run-in dose intervention 2: Sugammadex 4 mg/kg intervention 3: Sugammadex 16 mg/kg intervention 4: Placebo
Intervention descriptions: intervention 1: Single-blind placebo intravenous bolus injection on Day 1 of the study, 7 days prior to randomization intervention 2: Sugammadex 4 mg/kg intravenous bolus injection on Day 8, Day 36, and Day 78 of the study intervention 3: Sugammadex 16 mg/kg intravenous bolus injection on Day 8, Day 36, and Day 78 of the study intervention 4: Placebo intravenous bolus injection on Day 8, Day 36, and Day 78 of the study

Protocol document: