Evaluation of the Effects of Certolizumab Pegol on Semen Quality in Healthy Male Volunteers
Phase 1
Completed
- Conditions
- Sperm Quality
- Interventions
- Biological: Certolizumab pegolBiological: Placebo
- Registration Number
- NCT01091220
- Lead Sponsor
- UCB Pharma
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 20
Inclusion Criteria
- Healthy male volunteers with normal baseline semen quality parameters
Exclusion Criteria
- Previous participation in studies involving TNF inhibitors
- Prior treatment with biologic response modifiers within 5 half-lives
- History of trauma or surgery to the pelvis/genital area
- Tests positive for tuberculosis, HIV, Hepatitis B or C
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Certolizumab pegol Certolizumab pegol Certolizumab pegol 400 mg Placebo Placebo 0.9% saline
- Primary Outcome Measures
Name Time Method Total sperm motility (%) baseline to 99 days Sperm morphology (%) Baseline to 99 days
- Secondary Outcome Measures
Name Time Method Semen volume (mL) Baseline to 99 days Progressive motility (%) Baseline to 99 days Non-progressive motility (%) Baseline to 99 days Sperm vitality (%) Baseline to 99 days Sperm count (millions) Baseline to 99 days Sperm concentration (millions/mL) Baseline to 99 days