NCT00568594

Safety and Efficacy of APL180 in Healthy Volunteers and Patients With Coronary Heart Disease (CHD)

A First-in-human, Randomized, Double-blind, Placebo-controlled, Single-ascending Dose (Healthy Volunteers and CHD Patients) and Multiple Dose (CHD Patients) Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of APL180

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 176 (actual)
• Sponsor: Novartis · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine: (1) the safety and pharmacokinetics of APL180 administered as a single intravenous infusion in healthy volunteers, and (2) the safety, pharmacokinetics and pharmacodynamics of single and multiple daily intravenous infusions of APL018 in patients with CHD

Conditions

• Coronary Heart Disease

Interventions

Type	Name	Description
DRUG	APL180
DRUG	Placebo

Timeline

• Start date: 2007-11-01
• Primary completion: 2009-09-01
• First posted: 2007-12-06
• Last updated: 2020-12-24

Locations

11 sites across 7 countries: United States, Belgium, Denmark, Israel, Netherlands, South Africa, United Kingdom