A Phase 1, Randomized, Double-blind, Three-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics and Safety of Three Formulations of Omalizumab (CT-P39, EU-approved Xolair, and US-licensed Xolair) in Healthy Subjects
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Healthy
- Sponsor
- Celltrion
- Enrollment
- 176
- Locations
- 1
- Primary Endpoint
- Pharmacokinetic Outcome Measures [AUC0-inf] for Part 2
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
A Phase 1, Randomized, Double-blind, Three-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics and Safety of Three Formulations of Omalizumab (CT-P39, EU-approved Xolair, and US-licensed Xolair) in Healthy Subjects
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy subject (male or female) between the ages of 18 and 55 years.
- •Subject with a body weight of \> 40 kg and ≤ 90 kg and a BMI between 18.0 kg/m2 and 32.0 kg/m2(both inclusive).
- •Subject with a total IgE level of ≤ 100 IU/mL.
Exclusion Criteria
- •Subject has a medical history and/or current presence of disease including one or more of the allergic reaction.
Outcomes
Primary Outcomes
Pharmacokinetic Outcome Measures [AUC0-inf] for Part 2
Time Frame: up to day 127
Area Under the concentration-time Curve from time zero to infinity (AUC0-inf) of CT-P39, EU-approved Xolair, and US-licensed Xolair in healthy subjects (CT-P39 to EU-approved Xolair, CT-P39 to US-licensed Xolair, and EU-approved Xolair to US-licensed Xolair)
Pharmacokinetic Outcome Measures [Cmax] for Part 2
Time Frame: up to day 127
Maximum serum concentration (Cmax) of CT-P39, EU-approved Xolair, and US-licensed Xolair in healthy subjects (CT-P39 to EU-approved Xolair, CT-P39 to US-licensed Xolair, and EU-approved Xolair to US-licensed Xolair)
Pharmacokinetic Outcome Measures [AUC0-last] for Part 2
Time Frame: up to day 127
Area Under the concentration-time Curve from time zero to the last quantifiable concentration (AUC0-last) of CT-P39, EU-approved Xolair, and US-licensed Xolair in healthy subjects (CT-P39 to EU-approved Xolair, CT-P39 to US-licensed Xolair, and EU-approved Xolair to US-licensed Xolair)
Secondary Outcomes
- Pharmacodynamic Outcome Measures [Tmin of Free IgE] for Part 1 & Part 2(Up to day 127)
- Pharmacokinetic Outcome Measures [Tmax] for Part 1& Part 2(up to day 127)
- Pharmacodynamics Outcome Measures [Cmin of Free IgE] for Part 1 & Part 2(up to day 127)
- Pharmacodynamic Outcome Measures [Tmax of Total IgE] for Part 1 & Part 2(up to day 127)
- Pharmacokinetic Outcome Measures [t1/2] for Part 1& Part 2(up to day 127)
- Pharmacodynamic Outcome Measures [Cmax of Total IgE] for Part 1 & Part 2(up to day 127)