NCT01365663

Multiple Ascending Dose Study of SPC4955 in Healthy Subjects

A First-in-Human (FIH), Randomized, Dose-Escalation, Double-Blind, Placebo-Controlled Study to Assess Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SPC4955 Administered to Healthy Subjects

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

Summary

The purpose of this study is to study safety and tolerability of SPC4955 in healthy subjects.

Conditions

• Hypercholesterolemia

Interventions

Type	Name	Description
DRUG	SPC4955	3 Weekly SC injections
DRUG	SPC4955	3 Weekly SC injections
DRUG	SPC4955	3 Weekly SC injections
DRUG	SPC4955	3 Weekly SC injections
DRUG	SPC4955	3 Weekly SC injections
DRUG	Saline 0.9%	3 Weekly SC injections

Timeline

• Start date: 2011-05-01
• Primary completion: 2011-10-01
• Completion: 2011-11-01
• First posted: 2011-06-03
• Last updated: 2012-01-31

Locations

1 site across 1 country: Germany