Phase 1
Completed N=176
To Compare the PK and Safety of Omalizumab (CT-P39, EU-approved Xolair, and US-licensed Xolair) in Healthy Subjects
Healthy
Source: ClinicalTrials.gov NCT04018313 ↗
Enrolled (actual)
176
Serious AEs
0.6%
Results posted
May 2023
Primary outcomePrimary: Pharmacokinetic Outcome Measures [AUC0-inf] for Part 2 — 910.9; 897.7; 926.3 day*μg/mL
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pharmacokinetic Outcome Measures [AUC0-inf] for Part 2 |
910.9; 897.7; 926.3 | — |
| PRIMARY Pharmacokinetic Outcome Measures [AUC0-last] for Part 2 |
846; 843.8; 850.0 | — |
| PRIMARY Pharmacokinetic Outcome Measures [Cmax] for Part 2 |
20.08; 18.24; 19.43 | — |
| SECONDARY Pharmacokinetic Outcome Measures [Tmax] for Part 1& Part 2 |
7.178; 7.244; 7.098; 7.306; 7.183 | — |
| SECONDARY Pharmacokinetic Outcome Measures [t1/2] for Part 1& Part 2 |
29.75; 28.77; 29.30; 27.69; 28.63 | — |
| SECONDARY Pharmacodynamics Outcome Measures [Cmin of Free IgE] for Part 1 & Part 2 |
3.1538; 3.4613; 3.5267; 3.5590; 3.7002 | — |
| SECONDARY Pharmacodynamic Outcome Measures [Tmin of Free IgE] for Part 1 & Part 2 |
3.000; 5.196; 3.000; 5.051; 3.002 | — |
| SECONDARY Pharmacodynamic Outcome Measures [Cmax of Total IgE] for Part 1 & Part 2 |
241.5333; 165.2000; 245.2391; 174.2857; 219.5714 | — |
| SECONDARY Pharmacodynamic Outcome Measures [Tmax of Total IgE] for Part 1 & Part 2 |
28.263; 28.167; 28.191; 28.156; 28.087 | — |
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.
Data sourced from ClinicalTrials.gov (NCT04018313). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.