A Phase 1 interventional study of Certolizumab Pegol and Placebo in Healthy Subjects, sponsored by UCB Pharma SA. Completed at 1 site in China. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-08-14.
Sponsored by UCB Pharma SA · Phase 1, Interventional, and Treatment
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.
UCB Pharma SA is the lead sponsor of 28 studies on the registry; none are open to participants now.
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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.
Biological: Certolizumab Pegol · Other: Placebo
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.
Biological: Certolizumab Pegol · Other: Placebo
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.
Biological: Certolizumab Pegol · Other: Placebo
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.
Other: Placebo
* Active Substance: Certolizumab Pegol * Pharmaceutical Form: Prefilled syringes * Concentration: 200 mg/mL * Route of Administration: Subcutaneous injection
Also known as: Cimzia, CDP870, CZP
* Active Substance: Placebo * Pharmaceutical Form: Prefilled syringes * Concentration: 0.9 % Saline * Route of Administration: Subcutaneous injection
Also known as: PBO
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.
Time frame: 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.
Time frame: 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
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.
Time frame: 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
Time to reach a maximum plasma concentration (Tmax)
The time of occurrence of Cmax.
Time frame: 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.
Time frame: 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
This study is completed, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.
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