Trials / Completed
CompletedNCT04778137
The Study of Omalizumab (CMAB007 and Xolair) in Healthy Subjects to Compare the PK, PD and Safety
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 114 (actual)
- Sponsor
- Taizhou Mabtech Pharmaceutical Co.,Ltd · Industry
- Sex
- Male
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
Summary
A phase 1, randomized, double-blind, parallel group, single-dose study to compare the pharmacokinetics, pharmacodynamics and safety of two formulations of Omalizumab (CMAB007 and Xolair) in healthy subjects.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Omalizumab | Biological: CMAB007 Biological: Xolair |
Timeline
- Start date
- 2020-12-01
- Primary completion
- 2021-04-26
- Completion
- 2021-05-25
- First posted
- 2021-03-02
- Last updated
- 2021-10-11
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04778137. Inclusion in this directory is not an endorsement.