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

NCT ID: NCT01091220

Last Updated: 2011-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2011-03-31

Brief Summary

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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

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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.

Conditions

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Sperm Quality

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

0.9% saline

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

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

Certolizumab pegol

Certolizumab pegol 400 mg

Group Type EXPERIMENTAL

Certolizumab pegol

Intervention Type BIOLOGICAL

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

Interventions

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Certolizumab pegol

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

Intervention Type BIOLOGICAL

Placebo

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

Intervention Type BIOLOGICAL

Other Intervention Names

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Cimzia®

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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UCB Pharma

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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UCB Clinical Trial Call Center

Role: STUDY_DIRECTOR

+1 877 822 9493 (UCB)

Locations

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Liège, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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2009-015216-17

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CR0001

Identifier Type: -

Identifier Source: org_study_id

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