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Phase Ib/IIa Trial With AC01 in Patients With HFrEF — GOAL-HF1  

Heart Failure With Reduced Ejection Fraction Clinical Trial

Official title:
Randomized, Double-blind, Multiple Ascending Dose, Placebo-controlled, Safety, Tolerability, Efficacy, Pharmacokinetic (PK) and Pharmacodynamic (PD) Phase Ib/IIa Clinical Trial With AC01 in Patients With HFrEF

Clinical Trial Summary

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).

Clinical Trial Description

During the dose escalation phase, patients will be given AC01 orally twice daily for seven days. In the cohort expansion phase, patients will be given AC01 orally twice daily for 28 days at dose levels selected on the basis of results of the dose escalation phase. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05642507
Study type Interventional
Source AnaCardio AB
Contact Goran Westerberg, PhD
Phone +39 0577 803065
Email Goran.Westerberg@anacardio.com
Status Recruiting
Phase Phase 1/Phase 2
Start date February 23, 2023
Completion date June 30, 2025
View Details
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