A Dose-Finding Study of Amogammadex Sodium for Reversing Vecuronium and Rocuronium-Induced Neurom… (NCT07595393) | Clinical Trial Compass
Not Yet RecruitingPhase 2
A Dose-Finding Study of Amogammadex Sodium for Reversing Vecuronium and Rocuronium-Induced Neuromuscular Blockade
64 participantsStarted 2026-08-01
Plain-language summary
Background context: Amogammadex sodium has completed Phase I-III clinical studies in China for reversal of rocuronium-induced blockade. No clinical studies have yet been conducted for vecuronium-induced blockade. Therefore, this dose-finding study in an Australian population is intended to support further Phase III trials in European and American populations for reversal of both rocuronium- and vecuronium-induced neuromuscular blockade.
The goal of this clinical trial is to explore how well different doses of amogammadex sodium work to reverse neuromuscular blockade caused by rocuronium or vecuronium during surgery, and to learn about its safety. The main questions it aims to answer are:
* How quickly and effectively does amogammadex sodium restore muscle strength after moderate or deep neuromuscular blockade?
* What medical problems do participants have when receiving amogammadex sodium?
Researchers will compare different doses of amogammadex sodium to see which works best. All participants will receive amogammadex sodium, but at different dose levels depending on when they join the study.
Participants will:
* Undergo screening up to 28 days before surgery to confirm eligibility
* Receive amogammadex sodium at the end of surgery to reverse the effects of the muscle relaxant
* Stay in the study for follow-up visits up to 7 days after surgery.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Participants should be willing to participate in the clinical study; the participants should fully understand and know this study and sign an informed consent form; the participants should be willing to follow and be able to complete all study procedures.
. Male or female, 18 ≤ age ≤ 60.
. Participant with the grade of American Society of Anaesthesiologists (ASA) physical status classification 1-2.
. Participants who are scheduled to undergo approximately 2-hour surgery under TIVA with endotracheal intubation, and for whom vecuronium or rocuronium bromide is planned as the sole neuromuscular blocking agent.
. Body mass index (BMI) between 18 and 32 kg/m2 (both exclusive), and weight ≥ 50 kg for males and ≥ 45 kg for females.
. Willingness to use adequate contraception (abstinence is acceptable if it aligns with lifestyle) and refrain from pregnancy, impregnating a partner, or donating sperm/ova from screening until 3 months after study completion. Females of nonchildbearing potential are exempt.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Efficacy Evaluation: The time from the start of the administration of amogammadex sodium to the recovery of the TOFr to 0.9 on day 1.
Timeframe: Time from the start of the administration of IP to the recovery of the TOFr to 0.9 on day 1
. Intrauterine device in place for at least 3 months prior to dosing with a barrier method (condom or diaphragm) and spermicide (if available) throughout the study
. Double barrier methods (e.g., condom and diaphragm) with spermicide (if available) for at least 28 days prior to dosing and throughout the study
Exclusion criteria
. Known or expected difficult intubation due to anatomical deformities
. Known or suspected neuromuscular diseases, anatomical abnormality or neurological injury history that may affect neuromuscular transmission.
. History or manifestation of disease that, in the opinion of the investigator, renders the participant unsuitable for the study, including but not limited to nervous system, cardiovascular, blood, lymphatic, immune, kidney, liver, gastrointestinal, respiratory, metabolic, and musculoskeletal disorders.
. Participants with abnormal blood pressure not satisfactorily controlled (systolic blood pressure \>160 mmHg or \< 90 mmHg, diastolic blood pressure \> 100 mmHg or \< 60 mmHg). For subjects with systolic blood pressure ≥ 140 mmHg and ≤ 160 mmHg or diastolic blood pressure ≥ 90 mmHg and ≤ 100 mmHg and a history of well-controlled blood pressure, and no definite discomfort symptoms, the determination of clinical significance will be made at investigator discretion.
. Known heart failure or other serious cardiovascular diseases with New York Heart Association (NYHA) functional class III or IV; with abnormal ECG, QTcF interval (using Fridericia's formula) male \> 450 ms, female \> 470 ms, which is judged to have clinical significance by the investigators; with resting heart rate \< 60 bpm or \> 100 bpm, which is judged to have clinical significance by the investigators.
. History of human immunodeficiency virus (HIV); or positive results at screening for HIV antibody/antigen (HIV Ab/Ag)
. Hepatic insufficiency or known liver disease:
. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 2.0 × upper limit of normal (ULN);