Trial Profile

A Randomized Phase I, Double-Blinded, Parallel Comparative Assessment of PK, PD, Safety, and Immunogenicity of BP11 Versus US-Licensed Xolair® and EU Approved-Xolair Following a Single 150 mg Dose SC Administration in Healthy Male Volunteers

Status: Completed

Phase of Trial: Phase I

Latest Information Update: 11 Jun 2025

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At a glance

16 Mar 2024 Primary endpoint (To evaluate PK similarity of BP11 with US-Xolair and EU-Xolair and between US-Xolair and EU-Xolair) has been met, according to an Aurobindo Pharma media release.
16 Mar 2024 Primary endpoint (To evaluate pharmacokinetic (PK) similarity of BP11 with US-Xolair and EU-Xolair and between US-Xolair and EU-Xolair) has been met, according to an Aurobindo Pharma media release.
02 Jan 2024 Status changed from active, no longer recruiting to completed.

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