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

PHASE1CompletedINTERVENTIONAL
Enrollment

165

Participants

Timeline

Start Date

February 16, 2022

Primary Completion Date

January 10, 2024

Study Completion Date

January 10, 2024

Conditions
Healthy Volunteers
Interventions
DRUG

Omalizumab Prefilled Syringe

150mg/ml of Omalizumab prefilled syringe

Trial Locations (3)

1010

Auckland Clinical Studies Ltd (NZCR OpCo Limited), Grafton

4006

Q-Pharm Pty Ltd, Herston

8011

Christchurch Clinical Studies Trust Ltd (NZCR OpCo Limited), Christchurch

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

CuraTeQ Biologics Private Ltd.

UNKNOWN

lead

Syneos Health

OTHER