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PK, Safety, and Immunogenicity of Process-Changed CMAB007 vs Xolair in Healthy Chinese Males
NCT07246252Phase 1Completed
- Sponsor
- Taizhou Mabtech Pharmaceutical
- Start
- Mar 2024
- Primary completion
- Sep 2024
- Modality
- Monoclonal Antibodies
- Countries
- 1
01
Overview
Phase 1, randomised, double-blind trial of omalizumab in asthma and chronic spontaneous urticaria (CSU) (2 arms), sponsored by Taizhou Mabtech Pharmaceutical. Primary endpoints: Area Under the Plasma Concentration-time Curve From Zero (0) Hours Extrapolated to infinite time up to 2520 hours and Maximum Concentration of Omalizumab up to 2520 hours. Started Mar 2024; status: completed.
02
Drugs
omalizumab
03
Conditions
asthmachronic spontaneous urticaria (CSU)
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