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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
165
150mg/ml of Omalizumab prefilled syringe
Q-Pharm Pty Ltd
Herston, Queens Land, Australia
Auckland Clinical Studies Ltd (NZCR OpCo Limited)
Grafton, Auckland, New Zealand
Christchurch Clinical Studies Trust Ltd (NZCR OpCo Limited)
Christchurch, New Zealand
To evaluate pharmacokinetic (PK) similarity of BP11 with US-Xolair and EU-Xolair and between US-Xolair and EU-Xolair
AUC0-inf will be evaluated
Time frame: Upto 127 Days
To evaluate PK similarity of BP11 with US-Xolair and EU-Xolair and between US-Xolair and EU-Xolair
Cmax will be evaluated
Time frame: Upto 127 Days
To assess and compare non-primary PK parameters of BP11 with US-Xolair and EU-Xolair
AUC0-t
Time frame: Upto 127 Days
To assess and compare non-primary PK parameters of BP11 with US-Xolair and EU-Xolair
Vd
Time frame: Upto 127 Days
To assess and compare non-primary PK parameters of BP11 with US-Xolair and EU-Xolair
Tmax, T½
Time frame: Upto 127 Days
To assess and compare pharmacodynamics (PD) of BP11 with US-Xolair and EU-Xolair
Free IgE levels will be assessed
Time frame: Upto 127 Days
To assess and compare pharmacodynamics (PD) of BP11 with US-Xolair and EU-Xolair
Total IgE levels will be assessed
Time frame: Upto 127 Days
Safety & tolerability of BP11 with US-Xolair and EU-Xolair
Assessment of Vital signs-Blood pressure
Time frame: Upto 127 Days
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Safety & tolerability of BP11 with US-Xolair and EU-Xolair
Assessment of Vital signs-Pulse rate
Time frame: Upto 127 Days
Safety & tolerability of BP11 with US-Xolair and EU-Xolair
Assessment of Vital signs-Body temperature
Time frame: Upto 127 Days
Safety & tolerability of BP11 with US-Xolair and EU-Xolair
Assessment of Vital signs-Respiratory rate
Time frame: Upto 127 Days
Safety & tolerability of BP11 with US-Xolair and EU-Xolair
Normal 12 Lead ECG (Ventricular rate)
Time frame: Screening, Pre-dose (within 1 hour of drug administration) and post dose on day 3)
Safety & tolerability of BP11 with US-Xolair and EU-Xolair
Normal 12 Lead ECG (PR interval)
Time frame: Screening, Pre-dose (within 1 hour of drug administration) and post dose on day 3)
Safety & tolerability of BP11 with US-Xolair and EU-Xolair
Normal 12 Lead ECG (QRS complex)
Time frame: Screening, Pre-dose (within 1 hour of drug administration) and post dose on day 3)
Safety & tolerability of BP11 with US-Xolair and EU-Xolair
Normal 12 Lead ECG (QT interval and QT interval corrected for heart rate using Bazett's formula)
Time frame: Screening, Pre-dose (within 1 hour of drug administration) and post dose on day 3)
Safety & tolerability of BP11 with US-Xolair and EU-Xolair
Assessment of injection site reaction
Time frame: Pre-dose(0hour or within 1 hour prior of drug administration), post dose at 6hours, 12 hours and 24hours.