Aom0304 in Adult Patients With Symptomatic Hypertrophic Cardiomyopathy
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorAmckaus PTY LTD.
About this trial
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).
Eligibility criteria
Qualifiers
Able to understand and comply with the study procedures, understand the risks involved in the study, and provide written informed consent according to federal, local, and institutional guidelines before the first study-specific procedure.
Men or women participants aged 18 to 70 years (both inclusive) at Screening.
Documented diagnosed with HCM based on European Society of Cardiology/American College of Cardiology Foundation criteria: hypertrophied and non-dilated left ventricle in absence of other systemic or cardiac causes, with left ventricular wall thickness ≥ 15 mm at diagnosis or ≥ 13 mm with a positive family history of HCM, or a known gene mutation related to HCM.
Participants who are already treated with β-blockers, verapamil, diltiazem, or ranolazine should have been on stable doses for at least 4 weeks prior to Day 1 and anticipate remaining on the same medication regimen during the study.
Disqualifiers
Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 × upper limit of normal (ULN).
Total bilirubin > 2 × ULN.
Haemoglobin < 9 g/dL.
Platelet count < 100000/µL.
Trial design
Treatments tested in this trial
- QG101-23-0 enteric coated capsule (60/120/240/360 mg BID)
- QG101-23-0 enteric coated capsule (60/120/240/360 mg BID)
- QG101-23-0 enteric coated capsule (120/240/360/480mg BID)
- QG101-23-0 enteric coated capsule (60/120/240/360 mg BID)
Treatment groups
56 Participants
are divided into 3 treatment groupsLocations
Sponsors and collaborators
Amckaus PTY LTD.
Lead sponsor
Novotech (Australia) Pty Limited
Collaborator
Source ClinicalTrials.gov