Comparative Study to Evaluate the Pharmacokinetics of BAT2306 vs Cosentyx® in Healthy Subjects
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Psoriasis
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 55 years
- Gender
- Only males
Description
The study has a screening period of 14 days. PK blood samples will be collected from subjects to determine the serum concentration of Secukinumab, thus to evaluate the similarity of the pharmacokinetics of the three study drugs. The investigator will perform safety evaluation for vital signs, physic...
The study has a screening period of 14 days. PK blood samples will be collected from subjects to determine the serum concentration of Secukinumab, thus to evaluate the similarity of the pharmacokinetics of the three study drugs. The investigator will perform safety evaluation for vital signs, physical examinations, injection site reaction, ECG, clinical laboratory tests and adverse events throughout the study. Immunogenicity evaluation (ADA, ADA titration and NAb) will also be evaluated.
Tracking Information
- NCT #
- NCT04711343
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Yanhua Ding The First Hospital of Jinlin University
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