Absolute Bioavailability of Reslizumab in Healthy Subjects
Phase 1
Completed
- Conditions
- Absolute Bioavailability
- Interventions
- 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
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 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 Anti-reslizumab antibodies 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
Teva Investigational Site 10567🇺🇸Anaheim, California, United States