Single Ascending Doses of GGF2 in Patients With Left Ventricular Dysfunction and Symptomatic Heart Failure

Phase 1

Completed

Brief Summary: Study to determine the safety, tolerability, pharmacokinetics and immunogenicity of single intravenous administrations of GGF2 in patients with heart failure.

Detailed Description: Phase 1, double-blind, placebo-controlled, dose escalation study to determine the safety, tolerability, pharmacokinetics and immunogenicity of single intravenous administrations of GGF2 in cohorts of patients with left ventricular dysfunction and symptomatic heart failure.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Received any investigational agent or participation in any clinical study of an investigational agent or investigational therapy up to 30 days prior to the screening visit.
Use of any new prescription medication up to 14 days prior to receiving investigational drug.
Patients with known specific hepatic disease; bilirubin >2 mg/dL, SGOT > 100 IU.
Patients with a history of hepatic impairment (hepatitis B and C).
Serum creatinine >2.5 mg/dL.
Documented stroke or transient ischemic attack (TIA) within 60 days of study enrollment.

Arm && Interventions

Group	Intervention	Description
GGF2	Glial growth factor 2/ Neuregulin 1β3	Seven dosing cohorts: 2 patients randomized to receive 1 GGF2, 1 placebo; if no drug-related dose-limiting toxicities in GGF2-treated patient, other 4 patients in cohort will be randomized (3:1) and dosed
GGF2	Placebo	Seven dosing cohorts: 2 patients randomized to receive 1 GGF2, 1 placebo; if no drug-related dose-limiting toxicities in GGF2-treated patient, other 4 patients in cohort will be randomized (3:1) and dosed

Primary Outcome Measures

Name	Time	Method
Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs)	6 months	Safety/ tolerability of single dose; cumulative safety over 6 months TEAEs are defined as adverse events with date of onset (or worsening) on or after the start date of double-blind treatment and no more than 28 days from the start date of double-blind treatment.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline of Two-Dimensional Echocardiogram (2D-ECHO) Measured by Ejection Fraction (EF)	Screening, day 8, day 14, day 28, and 3 months post-dose	An echocardiogram is a type of ultrasound test that uses high-pitched sound waves that are sent through a device called a transducer. The device picks up echoes of the sound waves as they bounce off the different parts of your heart. These echoes are turned into moving pictures of your heart that can be seen on a video screen.¹ Ejection fraction is a measurement of the percentage of blood leaving your heart each time it contracts.² ¹http://wakeinternalmedicine.com/services-and-procedures/services/radiology/2d-echo/ ²http://www.mayoclinic.org/ejection-fraction/expert-answers/faq-20058286
Change From Baseline of 2D-ECHO Measured by End-Systolic Volume (ESV)	Screening, day 8, day 14, day 28, and 3 months post-dose	ESV is the volume of blood remaining in each ventricle at the end of systole.¹ ¹http://medical-dictionary.thefreedictionary.com/end-diastolic+volume
Change From Baseline of 2D-ECHO Measured by End-Diastolic Volume (EDV)	Screening, day 8, day 14, day 28, and 3 months post-dose	EDV is the amount of blood in the ventricle immediately before a cardiac contraction begins; used as a measurement of diastolic function.¹ ¹http://medical-dictionary.thefreedictionary.com/end-diastolic+volume

Locations (2): Vanderbilt University
🇺🇸
Nashville, Tennessee, United States
The Medical Group of Saint Joseph's
🇺🇸
Atlanta, Georgia, United States