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

UCB Pharma20 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

DOUBLE

Enrollment

Conditions

Sperm Quality

Interventions

Certolizumab pegolBIOLOGICAL

400 mg certolizumab pegol in 2 x 200 mg/mL, prefilled syringes, administered once, subcutaneously

PlaceboBIOLOGICAL

2 x prefilled syringes containing 0.9% saline, administered once, subcutaneously

Eligibility

Sex: MALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Liège, Belgium

Outcomes