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

UCB

Status and phase: Completed; Phase 1

Conditions: Sperm Quality

Treatments: Biological: Certolizumab pegol; Biological: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01091220

CR0001

2009-015216-17 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

20 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

0.9% saline

Treatment:

Biological: Placebo

Certolizumab pegol

Experimental group

Description:

Certolizumab pegol 400 mg

Treatment:

Biological: Certolizumab pegol