Status:
COMPLETED
To Compare the PK and Safety of Omalizumab (CT-P39, EU-approved Xolair, and US-licensed Xolair) in Healthy Subjects
Lead Sponsor:
Celltrion
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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-lic...
Eligibility Criteria
Inclusion
- 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
- Subject has a medical history and/or current presence of disease including one or more of the allergic reaction.
Key Trial Info
Start Date :
May 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2021
Estimated Enrollment :
176 Patients enrolled
Trial Details
Trial ID
NCT04018313
Start Date
May 28 2020
End Date
April 30 2021
Last Update
May 11 2023
Active Locations (2)
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1
Phase 1 unit
Herston, Queensland, Australia, 4006
2
Phase 1 unit
Adelaide, South Australia, Australia, 5000