drugset / Trial / NCT06494345

A Study of Genolair in Two Dosage Forms (Solution and Lyophilisate) and Xolair® in Healthy Volunteers

NCT06494345 ↗

Phase 1 Completed 180 enrolled AO GENERIUM
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

EvaluationDrugModalityDoseRoute
Subject Genolair Monoclonal antibody 150 mg Subcutaneous

Indications