Sperm Quality
Conditions
Keywords
certolizumab pegol, Cimzia®, healthy male volunteers, sperm
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.
Interventions
BIOLOGICALCertolizumab pegol
400 mg certolizumab pegol in 2 x 200 mg/mL, prefilled syringes, administered once, subcutaneously
BIOLOGICALPlacebo
2 x prefilled syringes containing 0.9% saline, administered once, subcutaneously
Sponsors
UCB Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total sperm motility (%) | baseline to 99 days |
| Sperm morphology (%) | Baseline to 99 days |
Secondary
| Measure | Time frame |
|---|---|
| Sperm vitality (%) | Baseline to 99 days |
| Semen volume (mL) | Baseline to 99 days |
| Progressive motility (%) | Baseline to 99 days |
| Sperm concentration (millions/mL) | Baseline to 99 days |
| Sperm count (millions) | Baseline to 99 days |
| Non-progressive motility (%) | Baseline to 99 days |
Countries
Belgium
Outcome results
None listed