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

• Status: Completed
• Trial end date: 2013-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Acorda Therapeutics
• Treatments: Mitogens

Criteria

Inclusion Criteria:

1. Left ventricular ejection fraction (LVEF) between 10% and 40%.

2. Male or female, aged 18 to 75 years, inclusive.

Exclusion Criteria:

1. 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.

2. Use of any new prescription medication up to 14 days prior to receiving investigational drug.

3. Patients with known specific hepatic disease; bilirubin >2 mg/dL, SGOT > 100 IU.

4. Patients with a history of hepatic impairment (hepatitis B and C).

5. Serum creatinine >2.5 mg/dL.

6. Documented stroke or transient ischemic attack (TIA) within 60 days of study enrollment.