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

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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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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