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| Name | Class |
|---|---|
| Parexel | INDUSTRY |
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This study will characterize the pharmacokinetics (PK) of certolizumab pegol (CZP) and evaluate safety of CZP in healthy Chinese subjects. 36 subjects will be randomized to receive one of 3 dose levels of CZP or placebo. The total study duration will be approximately 71-94 days for each subject.
This is a Phase 1, randomized, double-blind, placebo-controlled, single-center, single escalating dose study in healthy Chinese subjects. The primary objective of the study is to characterize the pharmacokinetics (PK) of certolizumab pegol (CZP) in healthy Chinese subjects after a single subcutaneous (sc) dose. The secondary objective is to evaluate safety of CZP in healthy Chinese subjects after a single sc dose. 36 healthy Chinese subjects (18 male and 18 female) will be randomized to receive one of 3 dose levels of CZP (100 mg, 200 mg and 400 mg) or placebo given by sc injections. Each dose group begins treatment staggered by a minimum of 14 days. The total duration of the study will be approximately 71 to 94 days for each subject. This includes a 2 to 21 days Screening Period, 1 day of treatment and 70 days Observation Period after administration of a single dose of investigational medicinal product.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Certolizumab Pegol 100 mg | Experimental | Subjects will receive100 mg of CZP given by subcutaneous injections in healthy Chinese subjects. The dose group begins treatment on Day 1. To achieve an injectable CZP 100 mg dose, a manual process will be applied by the unblinded site pharmacist. |
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| Certolizumab Pegol 200 mg | Experimental | Subjects will receive 200 mg of CZP given by subcutaneous injections in healthy Chinese subjects. The dose group begins treatment staggered by a minimum of 14 days from CZP 100 mg. Dose escalation will be suspended according to the predefined criteria and process. |
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| Certolizumab Pegol 400 mg | Experimental | Subjects will receive 400 mg of CZP (two injections of CZP 200 mg) given by subcutaneous injections in healthy Chinese subjects. The dose group begins treatment staggered by a minimum of 14 days from CZP 200 mg. Dose escalation will be suspended according to the predefined criteria and process. |
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| Placebo | Placebo Comparator | For assessment of the Adverse Event (AE) profile, there are 2 placebo controls in each dose group. The placebo subjects receive the injection of saline (NaCl 0.9 %) at the same time (and of the same volume) as the CZP subjects. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Certolizumab Pegol | Biological |
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| Measure | Description | Time Frame |
|---|---|---|
| The area under the plasma concentration-time curve from time zero up to the last analytically quantifiable concentration (AUC 0-t) | AUC 0-t is within a period of 70 days following the dose of CZP, reported in units of μg/mL·h, as determined using the linear trapezoidal rule. | D1 (pre-dose and 1, 2, 4, 8, 12 hrs post-dose), D2 (24, 36 hrs post-dose), D3 (48 hrs post-dose), D4 (72 hrs post-dose), D5 (96 hrs post-dose), D6, D8, D15, D22, D29, D43, D57 and D70 |
| Maximum plasma concentration (Cmax) | The maximum observed plasma concentration of CZP. | D1 (pre-dose and 1, 2, 4, 8, 12 hrs post-dose), D2 (24, 36 hrs post-dose), D3 (48 hrs post-dose), D4 (72 hrs post-dose), D5 (96 hrs post-dose), D6, D8, D15, D22, D29, D43, D57 and D70 |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration-time curve from zero up to infinity (AUC) | AUC is calculated as AUC=AUC(0-t)+Clast/λz, where Clast is the last quantifiable plasma concentration and λz is the apparent terminal elimination rate constant. | D1 (pre-dose and 1, 2, 4, 8, 12 hrs post-dose), D2 (24, 36 hrs post-dose), D3 (48 hrs post-dose), D4 (72 hrs post-dose), D5 (96 hrs post-dose), D6, D8, D15, D22, D29, D43, D57 and D70 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| UCB Clinical Trial Call Center | +1 877 822 9493 (UCB) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1 | Shanghai | China |
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| ID | Term |
|---|---|
| D000068582 | Certolizumab Pegol |
| ID | Term |
|---|---|
| D011092 | Polyethylene Glycols |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D007140 | Immunoglobulin Fab Fragments |
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| Placebo | Other |
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| Time to reach a maximum plasma concentration (Tmax) | The time of occurrence of Cmax. | D1 (pre-dose and 1, 2, 4, 8, 12 hrs post-dose), D2 (24, 36 hrs post-dose), D3 (48 hrs post-dose), D4 (72 hrs post-dose), D5 (96 hrs post-dose), D6, D8, D15, D22, D29, D43, D57 and D70 |
| Terminal half-life (t½) | t½ is reported in units of hours, as determined via simple linear regression (slope=-λz) of natural log(ln) concentration vs time for data points in the terminal phase of the concentration-tim curve. t½ is calculated as ln(2)/λz. | D1 (pre-dose and 1, 2, 4, 8, 12 hrs post-dose), D2 (24, 36 hrs post-dose), D3 (48 hrs post-dose), D4 (72 hrs post-dose), D5 (96 hrs post-dose), D6, D8, D15, D22, D29, D43, D57 and D70 |
| D007128 |
| Immunoglobulin Fragments |
| D010446 | Peptide Fragments |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |