This will be a randomized, double blind, three-arm, single dose, parallel group, PK, PD and safety and immunogenicity study in healthy, adult, subjects. Total 306 healthy, adult, eligible human subjects (102 in each treatment arm) will be enrolled in the study with their consent. Required \*standby subjects will also be enrolled to ensure that 306 subjects are dosed in the study. The study will be conducted in cohorts; all the study procedures will be identical as mentioned in the protocol for all the cohorts.
This will be a randomized, double blind, three-arm, single dose, parallel group, PK, PD and safety and immunogenicity study in healthy, adult, subjects. The study objectives will be to compare the pharmacokinetics (PK), pharmacodynamics (PD) and to evaluate safety and immunogenicity of the Test product Vs. US-LICENSED XOLAIR and Test product Vs. EU-APPROVED XOLAIR following single subcutaneous dose in healthy adult subjects. For the purpose of this study the following eligibility assessments will be carried out before enrollment / during the study of any volunteer in the study. Assessment criteria should be fulfilled for volunteers to be enrolled in the study. The screening will be carried out only after taking written informed consent from volunteers. Once the subject becomes eligible, will get randomized to receive either ADL-018, US-licensed XOLAIR or EU approved XOLAIR as per the randomization schedule. This will be parallel design so will have only one study period. After dosing, all subjects will go for serial PK sampling as defined in the study protocol. All subjects will be monitored on safety grounds as mentioned in the study protocol.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
306
150 mg/mL, Solution for injection in PFS
150 mg/mL, Solution for injection in PFS
150 mg/mL, Solution for injection in PFS
Registered BABE centre
Ahmedabad, Gujarat, India
Registered BABE Centre
Mahesāna, Gujarat, India
Pharmacokinetic Outcome Measures [Cmax]
Maximum serum concentration (Cmax) of ADL-018, EU approved Xolair, and US-licensed Xolair in healthy subjects (ADL-018 to EU approved Xolair, ADL-018 to US licensed Xolair, and EU-approved Xolair to US licensed Xolair)
Time frame: Upto Day 126
Pharmacokinetic Outcome Measures [AUC0-last]
Area Under the concentration-time Curve from time zero to the last quantifiable concentration (AUC0-last) of ADL-018, EU approved Xolair, and US-licensed Xolair in healthy subjects (ADL-018 to EU approved Xolair, ADL-018 to US licensed Xolair, and EU-approved Xolair to US licensed Xolair)
Time frame: Upto Day 126
Pharmacokinetic Outcome Measures [AUC0-inf]
Area Under the concentration-time Curve from time zero to infinity (AUC0-inf) of ADL-018, EU approved Xolair, and US-licensed Xolair in healthy subjects (ADL-018 to EU approved Xolair, ADL-018 to US licensed Xolair, and EU-approved Xolair to US licensed Xolair)
Time frame: Upto Day 126
Incidence of Adverse events of Special Interest [Safety]
Adverse events of Special Interest (AESI) of ADL-018, EU approved Xolair, and US-licensed Xolair in healthy subjects (e.g., Allergic reactions type 1/anaphylaxis, injection site reactions, serum sickness/serum sickness-like reactions, and parasitic infections)
Time frame: Upto Day 126
Pharmacokinetic Outcome Measures [Tmax]
To assess Time to Cmax (Tmax) of ADL-018, EU-approved Xolair, and US-licensed Xolair in healthy subjects
Time frame: Upto Day 126
Pharmacokinetic Outcome Measures [t1/2]
To assess Terminal half-life (t1/2) of ADL-018, EU-approved Xolair, and US-licensed Xolair in healthy subjects
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Time frame: Upto Day 126
Pharmacokinetic Outcome Measures [Apparent total body clearance (CL/F)]
To assess Apparent total body clearance (CL/F) of ADL-018, EU-approved Xolair, and US-licensed Xolair in healthy subjects
Time frame: Upto day 126
Pharmacokinetic Outcome Measures [λz]
To assess Terminal elimination rate constant (λz) of ADL-018, EU-approved Xolair, and US-licensed Xolair in healthy subjects
Time frame: Upto day 126
Pharmacokinetic Outcome Measures [Vz/F]
To assess apparent volume of distribution (Vz/F) of ADL-018, EU-approved Xolair, and US-licensed Xolair in healthy subjects
Time frame: Upto day 126
Pharmacodynamics [IgE level]
Free IgE and total IgE levels (the sum of free and omalizumab-bound IgE) in the serum samples from subjects
Time frame: Upto day 126
ADA incidence rate of ADL-018
Anti drug antibody(ADA)incidence rate of single subcutaneous administration of ADL-018 in comparison with US-licensed XOLAIR and EU-approved XOLAIR in healthy subjects
Time frame: Upto day 126