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NOT YET RECRUITING
NCT07595393
PHASE2

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

Sponsor: Amckaus PTY LTD.

View on ClinicalTrials.gov

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.

Official title: A Multi-Centre, Open-Label, Phase II Study of Amogammadex Sodium as A Reversal Agent for Vecuronium Bromide or Rocuronium Bromide-Induced Moderate (at the Reappearance of T2) and Deep (PTC=1~2) Neuromuscular Blockade in Participants Undergoing ASA Grade 1-2 Elective Surgery

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

64

Start Date

2026-08-01

Completion Date

2027-12-30

Last Updated

2026-05-19

Healthy Volunteers

No

Interventions

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.

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.