This is a randomized, double-blind, placebo-controlled two-part study with a multiple escalating dose phase followed by a cohort expansion phase to assess safety, tolerability, pharmacokinetics and pharmacodynamics of AC01 in patients with heart failure with reduced ejection fraction (HFrEF).
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Safety and tolerability: Adverse Events (AEs)
Timeframe: From first dose of study drug up to end of follow up (up to 12 days during dose escalation phase and up to 35 days during cohort expansion phase).
Safety and tolerability: Vital signs.
Timeframe: Baseline and end-of-treatment (Day 7 during the dose escalation and Day 28 during cohort expansion)
Safety and tolerability: Vital signs.
Timeframe: Baseline and end-of-treatment (Day 7 during the dose escalation and Day 28 during cohort expansion).
Safety and tolerability: Vital signs.
Timeframe: Baseline and end-of-treatment (Day 7 during the dose escalation and Day 28 during cohort expansion).
Safety and tolerability: Electrocardiogram (ECG).
Timeframe: From first dose of study drug up to end of follow up (up to 12 days during dose escalation phase and up to 35 days during cohort expansion phase).
Safety and tolerability: Electrocardiogram (ECG).
Timeframe: Baseline and end-of-treatment (Day 7 during the dose escalation and Day 28 during cohort expansion).
Safety and tolerability: Clinical laboratory evaluations.
Timeframe: Baseline and end-of-treatment (Day 7 during the dose escalation and Day 28 during cohort expansion).
Safety and tolerability: Clinical laboratory evaluations.
Timeframe: Baseline and end-of-treatment (Day 7 during the dose escalation and Day 28 during cohort expansion).
Safety and tolerability: Clinical laboratory evaluations.
Timeframe: Baseline and end-of-treatment (Day 7 during the dose escalation and Day 28 during cohort expansion).