NCT01091220

Evaluation of the Effects of Certolizumab Pegol on Semen Quality in Healthy Male Volunteers

A Randomized, Single-center, Double-blind, Placebo-controlled Study to Explore the Effect of a Single Dose of Certolizumab Pegol 400 mg on Semen Quality in Healthy Male Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: UCB Pharma · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The primary objective of this study is to evaluate the effect of certolizumab pegol (CZP) on the quality of sperm obtained from healthy male volunteers.

Detailed description

CZP is a PEGylated humanized Fab' fragment with specificity for human tumor necrosis factor alpha (TNFα). Evidence suggests that modulation of TNFα signaling may affect male spermatogenesis. Therefore, this study will compare semen quality parameters before and after a single 400 mg dose of CZP, or matched placebo.

Conditions

• Sperm Quality

Interventions

Type	Name	Description
BIOLOGICAL	Certolizumab pegol	400 mg certolizumab pegol in 2 x 200 mg/mL, prefilled syringes, administered once, subcutaneously
BIOLOGICAL	Placebo	2 x prefilled syringes containing 0.9% saline, administered once, subcutaneously

Timeline

• Start date: 2010-03-01
• Primary completion: 2011-03-01
• Completion: 2011-03-01
• First posted: 2010-03-23
• Last updated: 2011-09-05

Locations

1 site across 1 country: Belgium