NCT01082094

Study to Evaluate the Safety of a Single Escalating Dose of ACRX-100 in Adults With Ischemic Heart Failure

An Open Label Dose Escalation Study to Evaluate the Safety of a Single Escalating Dose of ACRX-100 Administered by Endomyocardial Injection to Cohorts of Adults With Ischemic Heart Failure

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Juventas Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this Phase 1 study is to assess the safety, tolerability, and preliminary efficacy of single escalating doses of ACRX-100 delivered via endomyocardial injection in adults with ischemic heart failure.

Detailed description

This open label, 16 subject, Phase 1 dose-escalation study will demonstrate the initial safety of using ACRX-100 to treat heart failure in subjects with ischemic cardiomyopathy. Safety will be tracked at each dose by documenting all adverse events (AEs), with the primary safety endpoint being the number of major cardiac AEs at 30 days. In each cohort (n=4 in low dose, n=6 each in mid and high dose), subjects will receive a single dose of ACRX-100. Preliminary efficacy will be evaluated by measuring the impact on cardiac function via standard echocardiography measurements, cardiac perfusion via SPECT imaging, and improvement in NYHA classification.

Conditions

• Heart Failure

Interventions

Type	Name	Description
BIOLOGICAL	ACRX-100	Three cohorts (16 total subjects) will be studied. There will be no concurrent controls. The dose will be escalated by increasing the total amount of ACRX-100 delivered per subject from low dose (n=4 subjects) to middle dose (n=6 subjects) to high dose (n=6 subjects). ACRX-100 will be injected directly into the myocardium as a single dose at multiple sites through a percutaneous, left ventricular approach using a needle injection catheter.

Timeline

• Start date: 2010-02-01
• Primary completion: 2012-01-01
• Completion: 2012-01-01
• First posted: 2010-03-08
• Last updated: 2012-06-06

Locations

4 sites across 1 country: United States