NCT01276119

The First Clinical Study to Test Safety, Blood Levels and Other Effects of CDP6038 in Healthy Males

A Phase 1, Randomized, Double-blind, Placebo-controlled, Single-center, Single-dose, Dose-escalating Study to Evaluate the Safety and Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of CDP6038 in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: UCB Pharma · Industry
• Sex: Male
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

To evaluate the safety, tolerability, blood levels and effects of CDP6038 administered by intravenous infusion (iv) and subcutaneous (sc) injection.

Conditions

• Pharmacokinetics

Interventions

Type	Name	Description
BIOLOGICAL	CDP6038	100 mg/mL solution for injection Single infusion over 60 minutes
BIOLOGICAL	CDP6038	100 mg/mL solution for injection Single infusion over 120 minutes
BIOLOGICAL	CDP6038	100 mg/mL solution for injection Single sc injection
OTHER	Placebo	0.9% sodium chloride for injection Single infusion over 60 minutes
OTHER	Placebo	0.9% sodium chloride for injection Single infusion over 120 minutes
OTHER	Placebo	0.9% sodium chloride for injection Single sc injection

Timeline

• Start date: 2008-09-01
• Primary completion: 2009-10-01
• Completion: 2009-10-01
• First posted: 2011-01-13
• Last updated: 2012-03-22

Locations

1 site across 1 country: Germany