Comparison of Pharmacokinetics and Safety of HS632 and Xolair® With a Single Injection
- Sponsor
- BioRay Pharmaceutical Co., Ltd.
- Study ID
- NCT04361812
- Phase
- PHASE1
- Status
- Terminated
Conditions
- Similarity of Pharmacokinetics and Safety
Eligibility Criteria
- Sex
- MALE
- Age
- 18 Years - 40 Years
- Healthy Volunteers
- Accepted
Interventions
- HS632 — DRUGSubcutaneous injection of HS632
- Omalizumab (Xolair®) — DRUGSubcutaneous injection of Omalizumab Xolair®)
Study Details
To evaluate the bioequivalence of HS632 and Omalizumab (Xolair®) in a single subcutaneous administration in healthy subjects.
Key Dates
- First listed
- Apr 24, 2020
- Start date
- Oct 15, 2020
- Status verified
- Nov 2025
- Primary completion
- Dec 31, 2021
- Completion
- Dec 31, 2021
Study Design
- Enrollment
- 1 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: HS632HS632 150mg for a single subcutaneous injection
- Active Comparator: Omalizumab (Xolair®)Omalizumab 150mg for a single subcutaneous injection
Primary Outcome Measure
AUC(0 -∞) of single subcutaneous administration of HS632 and Xolair in healthy subjects [ Time Frame: 13weeks ]