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| Name | Class |
|---|---|
| Parexel | INDUSTRY |
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This is a single center, open-label, Phase 1 bioequivalence (BE) study in healthy subjects designed to demonstrate the bioequivalence of a single dose of certolizumab pegol (CZP) 200mg when injected by means of a prefilled syringe (PFS, reference) or injected by means of a injection device (e-Device, test).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Certolizumab Pegol injection by prefilled syringe | Active Comparator |
| |
| Certolizumab Pegol injection by e-Device | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prefilled syringe (PFS) | Device | Active substance: Certolizumab Pegol Pharmaceutical form: Solution for injection Administration: By prefilled syringe (PFS) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) | Predose on Day 1 and at 12 hours postdose, and on days 2, 3, 4, 5, 6, 7, 10, 14, 21, 28, 42, 56, 70. | |
| Area under the CZP plasma concentration-time curve from time 0 to infinity (AUC) | Predose on Day 1 and at 12 hours postdose, and on days 2, 3, 4, 5, 6, 7, 10, 14, 21, 28, 42, 56, 70. | |
| Area under the CZP plasma concentration-time curve from time 0 to last observed quantifiable concentration (AUC(0-t)) | Predose on Day 1 and at 12 hours postdose, and on days 2, 3, 4, 5, 6, 7, 10, 14, 21, 28, 42, 56, 70. |
| Measure | Description | Time Frame |
|---|---|---|
| Time of observed Cmax (tmax) | Predose on Day 1 and at 12 hours postdose, and on days 2, 3, 4, 5, 6, 7, 10, 14, 21, 28, 42, 56, 70. | |
| Terminal elimination half-life (t1/2) | Predose on Day 1 and at 12 hours postdose, and on days 2, 3, 4, 5, 6, 7, 10, 14, 21, 28, 42, 56, 70. |
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Inclusion Criteria:
Female subjects who are postmenopausal for at least 2 years and have a serum follicle stimulating hormone (FSH) level >40mIU/mL at the Screening Visit, or have undergone a hysterectomy, bilateral tubal ligation, and/or bilateral ovariectomy, or have a congenital sterility are considered not of childbearing potential.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| UCB Cares | UCB Pharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ra0132 001 | Baltimore | Maryland | United States |
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| e-Device | Device | Active substance: Certolizumab Pegol Pharmaceutical form: Solution for injection Administration: By e-Device |
|
| Apparent total body clearance (CL/F) | Predose on Day 1 and at 12 hours postdose, and on days 2, 3, 4, 5, 6, 7, 10, 14, 21, 28, 42, 56, 70. |
| Apparent volume of distribution (Vz/F) | Predose on Day 1 and at 12 hours postdose, and on days 2, 3, 4, 5, 6, 7, 10, 14, 21, 28, 42, 56, 70. |