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Phase Ib/IIa Trial With AC01 in Patients With HFrEF - Trial NCT05642507

Access comprehensive clinical trial information for NCT05642507 through Pure Global AI's free database. This Phase 1/2 trial is sponsored by AnaCardio AB and is currently Recruiting. The study focuses on Heart Failure With Reduced Ejection Fraction. Target enrollment is 80 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.

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NCT05642507
Phase 1/2
Recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT05642507
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Phase Ib/IIa Trial With AC01 in Patients With HFrEF
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

Study Focus

AC01

Interventional

drug

Sponsor & Location

AnaCardio AB

Stockholm, Sweden

Timeline & Enrollment

Phase 1/2

Feb 23, 2023

Nov 01, 2024

80 participants

Primary Outcome

Safety and tolerability: Adverse Events (AEs),Safety and tolerability: Vital signs.,Safety and tolerability: Vital signs.,Safety and tolerability: Electrocardiogram (ECG).,Safety and tolerability: Clinical laboratory evaluations.

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).

ICD-10 Classifications

Heart failure
Congestive heart failure
Heart failure, unspecified
Hypertensive heart disease with (congestive) heart failure
Left ventricular failure

Data Source

ClinicalTrials.gov

NCT05642507

Non-Device Trial