A Phase 2, Multi-Regional, Open-label, Three-Part Study to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetics of Aom0304 in Adult Patients With Symptomatic Hypertrophic Cardiomyopathy
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).
Single-center, Randomised, Double-blind, Placebo-controlled Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profile of Single- and Multiple-dose Ascending Oral QG101-23-0 Capsules in Healthy Subjects
The study will consist of three parts: a single-dose ascending (SAD) phase (Part A) enrolling a total of five
six cohorts of healthy participants, a multiple-dose ascending (MAD) phase (Part B) enrolling 3 cohorts of healthy participants, and a food effect study (Part C).
100 项与 QG101-23-0 相关的临床结果
100 项与 QG101-23-0 相关的转化医学
100 项与 QG101-23-0 相关的专利（医药）
100 项与 QG101-23-0 相关的药物交易
