Clinical trials

The goal of this clinical trial is designed to characterise the safety, tolerability, efficacy, and PK of Aom0304 across oHCM and nHCM populations and to inform dose selection for future Phase 3 development. The main questions it aims to answer are: 1. Which dose is safe and tolerant of Aom0304 in participants with HCM? 2. Which dose is effective of 12 weeks of Aom0304 treatment in participants with oHCM or nHCM? Researchers will compare different doses of Aom0304 to see which works best. All participants will receive Aom0304, but at different dose levels depending on which cohort they joined. Participants will: 1. Undergo screening up to 28 days before enrollment to confirm eligibility 2. Adjust dose every 2 weeks assessed by the Investigator according to predefined criteria at Titration Phase (Week 1 Day 1 to Week 8). 3. Continuation of the last tolerated and effective dose; no further escalation is permitted at Maintenance Phase (Week 8 to Week 12). 4. Study drug discontinued and follow up at Off-treatment Follow-up Period (at the end of Week 12 to Week 16).

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.