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Phase Ib/IIa Trial With AC01 in Patients With HFrEF

NCT05642507 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2026-05-07

No results posted yet for this study

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).

Conditions

  • Heart Failure With Reduced Ejection Fraction

Interventions

DRUG

AC01

AC01 Minitablets

DRUG

Placebo Minitablets

Placebo Minitablets are indistinguishable from active AC01 Minitablets.

Sponsors & Collaborators

  • AnaCardio AB

    lead INDUSTRY

Principal Investigators

  • Lars H Lund, MD PhD · Karolinska University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-23
Primary Completion
2025-10-27
Completion
2025-10-27

Countries

  • Italy
  • Netherlands
  • Sweden
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05642507 on ClinicalTrials.gov