Absolute Bioavailability of Reslizumab in Healthy Subjects

Phase 1

Completed

• Conditions: Absolute Bioavailability
• Interventions: Drug: Reslizumab SC; Drug: Reslizumab IV

• Registration Number: NCT01990443
• Lead Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

Brief Summary

The primary objective of this study is to assess the absolute bioavailability of reslizumab following administration of a single subcutaneous (sc) dose to healthy non-Japanese participants

Detailed Description

The study is designed to assess the pharmacokinetics, safety and tolerability, immunogenicity, and pharmacodynamics of reslizumab

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-11-15
• Study First Submitted QC: 2013-11-15
• Study First Posted: 2013-11-21
• Primary Completion: 2013-12
• Status Verified: 2014-03
• Study Completion: 2014-03
• Last Update Submitted: 2014-03-27
• Last Update Posted: 2014-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Reslizumab SC	Reslizumab SC	Reslizumab 220-mg administered Subcutaneously (SC)
Reslizumab IV	Reslizumab IV	Reslizumab 220-mg administered Intravenously (IV)

Primary Outcome Measures

Name	Time	Method
Absolute bioavailability	From baseline to Day 140	Absolute bioavailability calculated as (AUC0-∞)sc/(AUC0-∞)

Secondary Outcome Measures

Name	Time	Method
Anti-reslizumab antibodies	From baseline to Day 140
Blood Eosinophils Levels	From baseline to Day 140
Summary of Participants with Adverse Events	From signing of consent form to Day 140
Blood samples for measurement of Anti-reslizumab antibodies	Baseline, days 14, 28, 84, 140
Volume of distribution (Vz)	From baseline to Day 140
Maximum observed serum drug concentration (Cmax)	From baseline to Day 140
Associated elimination half-life (t½)	From baseline to Day 140
Total serum clearance (CL)	From baseline to Day 140
Area under the serum drug concentration by time curve from time 0 to infinity (AUC0-∞)	From baseline to Day 140
Time to maximum observed serum drug concentration (tmax)	From baseline to Day 140
AUC from time 0 to the time of the last measurable drug concentration (AUC0-t)	From baseline to Day 140
Percentage extrapolation	From baseline to Day 140	Percentage extrapolation will be calculated as (AUC0-∞-AUC0-t)/(AUC0-∞)x100
Apparent serum terminal elimination rate constant (λz)	From baseline to Day 140

Trial Locations

Locations (1)

Teva Investigational Site 10567; 🇺🇸 Anaheim, California, United States