drugset / Trial / NCT06494345
A Study of Genolair in Two Dosage Forms (Solution and Lyophilisate) and Xolair® in Healthy Volunteers
RandomizedParallel-groupOpen-labelOther
Summary
This is a phase I an open-label randomized comparative study in parallel groups of pharmacokinetics, pharmacodynamics, immunogenicity, and safety of Genolair in two dosage forms (solution for subcutaneous administration and lyophilisate for the preparation of solution for subcutaneous administration) and Xolair® in healthy volunteers
Timeline
- Start
- 2023-01-15
- Primary completion
- 2024-06-09
- Completion
- 2024-06-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Genolair | Monoclonal antibody | 150 mg | Subcutaneous |