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

Sperm Quality Clinical Trial

Official title: 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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Sperm Quality

• NCT number: NCT01091220
• Study type: Interventional
• Source: UCB Pharma
• Status: Completed
• Phase: Phase 1
• Start date: March 2010
• Completion date: March 2011