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

Phase 1 Completed 165 enrolled Syneos Health CuraTeQ Biologics Private Ltd. · collab

RandomizedParallel-groupQuadruple-blindOther

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.

Timeline

Start: 2022-02-16
Primary completion: 2024-01-10
Completion: 2024-01-10

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Omalizumab	Monoclonal antibody	150 mg	Subcutaneous

Indications

No indication recorded.