At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 98 enrolled
Drug / intervention
Certolizumab pegol +1 moredrug
Likely dose
Certolizumab pegol 400 mg total (2 injections of 200 mg/mL)AI-extracted
Key inclusion· 5
- ✓Age 18-55 years
- ✓BMI 18-28 kg/m²
- ✓Good physical and mental health with normal ECG and clinical labs
- ✓Negative QuantiFERON-TB test
Key exclusion· 9
- ✕History of significant disease or allergies
- ✕History of drug and/or alcohol abuse
- ✕Known intolerance to PEG
- ✕Previously received certolizumab pegol
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Open Label, Randomized, Parallel Group, Single Dose, 2-way Comparison Bioequivalence Study of Certolizumab Pegol Solution Injected Either by a Pre-filled Syringe (Reference) or by an Auto-injection Device (Test) to Healthy Volunteers.
In Brief
A Phase 1 clinical trial evaluating Certolizumab pegol for Healthy. Completed, enrolled 98 participants across 1 site.
Detailed 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 device (test).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesFrance
Collaborators--
Timeline
Phase 1CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartOct 2007
Primary CompletionApr 2008
First PostedFeb 2009
TodayJul 2026
First PostedFeb 18, 2009
Enrollment StartOct 1, 2007
Primary CompletionApr 1, 2008
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 17.4 years ago
Interventions
Certolizumab pegoldrug
Auto-injection device (test) containing 1 mL of certolizumab pegol liquid formulation, 200 mg/mL; 2 injections
Certolizumab pegoldrug
Pre-filled syringe (reference) containing 1 mL of certolizumab pegol liquid formulation, 200 mg/mL; 2 injections