NCT05053334

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

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: Phase 1
• Study type: Interventional
• Enrollment: 165 (actual)
• Sponsor: Syneos Health · Academic / Other
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

The study will be conducted at 2 sites in New Zealand and 1 site in Australia. A total of 165 healthy male subjects (55 subjects per arm) who meet the required entry criteria will be randomly assigned to one of 3 treatment groups in a 1:1:1 ratio to receive a single SC injection of either BP11, EU-Xolair, or US-Xolair.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Omalizumab Prefilled Syringe	150mg/ml of Omalizumab prefilled syringe

Timeline

• Start date: 2022-02-16
• Primary completion: 2024-01-10
• Completion: 2024-01-10
• First posted: 2021-09-22
• Last updated: 2025-06-05

Locations

3 sites across 2 countries: Australia, New Zealand

Regulatory

• FDA-regulated drug study