NCT02365948

A Study of Certolizumab Pegol to Evaluate Pharmacokinetics and Safety in Adult Healthy Chinese Subjects

A Randomized, Double-blind, Placebo-controlled, Single Escalating Dose Study of Subcutaneous Certolizumab Pegol (CZP) to Evaluate the Pharmacokinetics and Safety of CZP in Healthy Chinese Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: UCB Pharma SA · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
BIOLOGICAL	Certolizumab Pegol	* Active Substance: Certolizumab Pegol * Pharmaceutical Form: Prefilled syringes * Concentration: 200 mg/mL * Route of Administration: Subcutaneous injection
OTHER	Placebo	* Active Substance: Placebo * Pharmaceutical Form: Prefilled syringes * Concentration: 0.9 % Saline * Route of Administration: Subcutaneous injection

Timeline

• Start date: 2015-03-01
• Primary completion: 2015-08-01
• Completion: 2015-08-01
• First posted: 2015-02-19
• Last updated: 2015-08-14

Locations

1 site across 1 country: China