Overview

Biosimilar Study Comparing PK, PD, Safety and Immunogencity of BP11 With US Licensed Xolair and EU Approved Xolair

Status:
Not yet recruiting

Trial end date:
2022-10-01

Target enrollment:

Participant gender:

Summary

A single dose, double blind comparative trial to assess the pharmacokinetics, pharmacodynamics, safety and immunogenicity of 3 different products (BP11, US-Xolair and EU-Xolair) containing 150mg of Omalizumab as subcutaneous injection in healthy male volunteers.

Phase:

Phase 1

Details

Lead Sponsor:

Syneos Health

Collaborator:

CuraTeQ Biologics Private Ltd.

Treatments:

Omalizumab