Status:
COMPLETED
Comparison Bioequivalence Study: Pre-filled Syringe (Reference) Versus Auto-injection Device (Test)
Lead Sponsor:
UCB Pharma
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
To compare the bioavailability of a single 400 mg dose of certolizumab pegol solution (2 x 200mg subcutaneous injections) injected either by a pre-filled syringe (reference) or by an auto-injection de...
Eligibility Criteria
Inclusion
- Age: 18-55 years.
- A Body mass Index (BMI) of 18 to 28 kg/m
- Good physical and mental health status determined on the basis of the medical history and a general clinical examination
- Electrocardiogram and clinical laboratory tests interpreted as "normal"
- QuantiFERON-TB test negative
- female subjects: medically accepted method of contraception
Exclusion
- prohibited concomitant medication
- administered vaccines and immunoglobulins in the month preceding the certolizumab pegol injection
- history of significant disease, allergies
- history of drug and/or alcohol abuse
- hepatic enzyme inducing drug within 2 months before study drug administration
- any drugs having influence of the immune response and antibiotic in the month preceding the inclusion
- known to be intolerant to PEG
- previously received certolizumab pegol
- previously received an antibody product within 5-half lives of the antibody or within 3 months of the start of the study
- history of tuberculosis
- have serum hepatitis or is carrier of the Hepatitis B surface antigen (HBs Ag), or Hepatitis C antibody or who is HIV positive
Key Trial Info
Start Date :
October 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT00845663
Start Date
October 1 2007
End Date
April 1 2008
Last Update
August 31 2011
Active Locations (1)
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1
Rennes, France