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

NCT05053334 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 165

Last updated 2025-06-05

No results posted yet for this study

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.

Conditions

  • Healthy Volunteers

Interventions

DRUG

Omalizumab Prefilled Syringe

150mg/ml of Omalizumab prefilled syringe

Sponsors & Collaborators

  • CuraTeQ Biologics Private Ltd.

    collaborator UNKNOWN

  • Syneos Health

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-02-16
Primary Completion
2024-01-10
Completion
2024-01-10
FDA Drug
Yes

Countries

  • Australia
  • New Zealand

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05053334 on ClinicalTrials.gov