drugset / Trial / NCT07246252
Compare the PK, Safety, and Immunogenicity of Process-Changed CMAB007 and Xolair in Healthy Adult Male Subjects
RandomizedParallel-groupTriple-blindTreatment
Summary
A phase 1, randomized, double-blind, parallel group, single-dose study to compare the pharmacokinetics, safety and immunogenicity of two formulations of Omalizumab (Process-Changed CMAB007 and Xolair) in healthy subjects.
Timeline
- Start
- 2024-03-28
- Primary completion
- 2024-09-30
- Completion
- 2024-12-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CMAB007 | Monoclonal antibody | 150 mg | Subcutaneous |
| Comparator | Omalizumab | Monoclonal antibody | 150 mg | Subcutaneous |
Indications
No indication recorded.