NCT01990443

Absolute Bioavailability of Reslizumab in Healthy Subjects

A Randomized, Open-Label, Parallel-Group, Single-Dose Study to Characterize the Absolute Bioavailability of Reslizumab (220 mg) Following Subcutaneous Administration to Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Teva Branded Pharmaceutical Products R&D, Inc. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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

Conditions

• Absolute Bioavailability

Interventions

Type	Name	Description
DRUG	Reslizumab IV	Reslizumab 220-mg intravenous (IV)
DRUG	Reslizumab SC	Reslizumab 220 mg administered subcutaneous (SC)

Timeline

• Start date: 2013-06-01
• Primary completion: 2013-12-01
• Completion: 2014-03-01
• First posted: 2013-11-21
• Last updated: 2014-03-31

Locations

1 site across 1 country: United States