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

NCT02365948 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2015-08-14

No results posted yet for this study

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.

Conditions

  • Healthy Subjects

Interventions

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

Sponsors & Collaborators

  • Parexel

    collaborator INDUSTRY

  • UCB Pharma SA

    lead INDUSTRY

Principal Investigators

  • UCB Clinical Trial Call Center · +1 877 822 9493 (UCB)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2015-08-31
Completion
2015-08-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02365948 on ClinicalTrials.gov