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A Dose-Finding Study of Amogammadex Sodium for Reversing Vecuronium and Rocuronium-Induced Neuromuscular Blockade

NCT07595393 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2026-05-19

No results posted yet for this study

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.

Conditions

  • Reversing Vecuronium-Induced Neuromuscular Blockade in Patients Undergoing General Anesthesia Surgery
  • Reversing Rocuronium-Induced Neuromuscular Blockade in Patients Undergoing General Anesthesia Surgery

Interventions

DRUG

vecuronium bromide (0.1mg/kg)

A single-dose intravenous bolus of 0.10 mg/kg vecuronium bromide， additional 0.015 mg/kg can be provided based on the required depth of neuromuscular blockade for surgery.

DRUG

Rocuronium (0.6mg/kg)

a single-dose intravenous bolus of 0.6 mg/kg rocuronium bromide，additional 0.1-0.2 mg/kg can be provided based on the required depth of neuromuscular blockade for surgery.

Sponsors & Collaborators

  • Novotech (Australia) Pty Limited

    collaborator INDUSTRY

  • Amckaus PTY LTD.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-01
Primary Completion
2027-06-30
Completion
2027-12-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07595393 on ClinicalTrials.gov