Trials / Terminated
TerminatedNCT04361812
Comparison of Pharmacokinetics and Safety of HS632 and Xolair® With a Single Injection
A Multicenter, Randomized, Double-blind, Parallel Controlled，Single-dose Phase I Study Comparing the Pharmacokinetic and Safety Similarities of Recombinant Anti IgE Humanized Monoclonal Antibody (HS632) With Omalizumab a in Healthy Subjects
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 1 (actual)
- Sponsor
- BioRay Pharmaceutical Co., Ltd. · Industry
- Sex
- Male
- Age
- 18 Years – 40 Years
- Healthy volunteers
- Accepted
Summary
To evaluate the bioequivalence of HS632 and Omalizumab (Xolair®) in a single subcutaneous administration in healthy subjects.
Detailed description
This is a multicenter, randomized, double-blind, parallel controlled，single-dose phase I study to compare the pharmacokinetic and safety similarities of recombinant anti IgE humanized monoclonal antibody (HS632) With omalizumab a in Chinese healthy subjects.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | HS632 | Subcutaneous injection of HS632 |
| DRUG | Omalizumab (Xolair®) | Subcutaneous injection of Omalizumab Xolair®) |
Timeline
- Start date
- 2020-10-15
- Primary completion
- 2021-12-31
- Completion
- 2021-12-31
- First posted
- 2020-04-24
- Last updated
- 2025-11-21
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04361812. Inclusion in this directory is not an endorsement.