NCT01350960

Multiple Ascending Dose Study of SPC5001 in Treatment of Healthy Subjects and Subjects With FH

A First-in-Human (FIH), Randomized, Dose-Escalation, Double-Blind, Placebo-Controlled Study to Assess Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SPC5001 Administered to Healthy Subjects and Subjects With Familial Hypercholesterolemia (FH)

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Santaris Pharma A/S · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose is to study Safety and Tolerability.

Conditions

• Hypercholesterolemia

Interventions

Type	Name	Description
DRUG	SPC5001	3 weekly SC injections
DRUG	Saline 0.9%	3 weekly SC injections
DRUG	SPC5001	3 weekly SC injections
DRUG	SPC5001	3 weekly SC injections
DRUG	SPC5001	3 weekly SC injections
DRUG	SPC5001	3 weekly SC injections

Timeline

• Start date: 2011-05-01
• Primary completion: 2011-10-01
• Completion: 2011-11-01
• First posted: 2011-05-10
• Last updated: 2011-11-22

Locations

1 site across 1 country: Netherlands