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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04018313




Registration number
NCT04018313
Ethics application status
Date submitted
9/07/2019
Date registered
12/07/2019
Date last updated
11/06/2020

Titles & IDs
Public title
To Compare the PK and Safety of Omalizumab(CT-P39, EU-approved Xolair, and US-licensed Xolair) in Healthy Subjects
Scientific title
A Phase 1, Randomized, Double-blind, Three-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics and Safety of Three Formulations of Omalizumab (CT-P39, EU-approved Xolair, and US-licensed Xolair) in Healthy Subjects
Secondary ID [1] 0 0
CT-P39 1.1
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - CT-P39
Other interventions - EU-approved Xolair
Other interventions - CT-P39
Other interventions - EU-approved Xolair
Other interventions - US-licensed Xolair

Experimental: CT-P39 (Part 1) - 150 mg/mL, Solution for injection in PFS

Active Comparator: EU-approved Xolair (Part 1) - 150 mg/mL, Solution for injection in PFS

Experimental: CT-P39 (Part 2) - 150 mg/mL, Solution for injection in PFS

Active Comparator: EU-approved Xolair (Part 2) - 150 mg/mL, Solution for injection in PFS

Active Comparator: US-licensed Xolair (Part 2) - 150 mg/mL, Solution for injection in PFS


Other interventions: CT-P39
150 mg/mL, Solution for injection in PFS

Other interventions: EU-approved Xolair
150 mg/mL, Solution for injection in PFS

Other interventions: CT-P39
150 mg/mL, Solution for injection in PFS

Other interventions: EU-approved Xolair
150 mg/mL, Solution for injection in PFS

Other interventions: US-licensed Xolair
150 mg/mL, Solution for injection in PFS

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of Treatment-Emergent Adverse Events [Safety] - Treatment-Emergent Adverse Events (TEAEs) of CT-P39, compared to that of EU-approved Xolair in healthy subjects
Timepoint [1] 0 0
up to day 127
Primary outcome [2] 0 0
Pharmacokinetic Outcome Measures [AUC0-inf] - Area Under the concentration-time Curve from time zero to infinity (AUC0-inf) of CT-P39, EU approved Xolair, and US-licensed Xolair in healthy subjects (CT-P39 to EU approved Xolair, CT-P39 to US licensed Xolair, and EU-approved Xolair to US licensed Xolair)
Timepoint [2] 0 0
up to day 127
Primary outcome [3] 0 0
Pharmacokinetic Outcome Measures [AUC0-last] - Area Under the concentration-time Curve from time zero to the last quantifiable concentration (AUC0-last) of CT-P39, EU approved Xolair, and US-licensed Xolair in healthy subjects (CT-P39 to EU approved Xolair, CT-P39 to US licensed Xolair, and EU-approved Xolair to US licensed Xolair)
Timepoint [3] 0 0
up to day 127
Primary outcome [4] 0 0
Pharmacokinetic Outcome Measures [Cmax] - Maximum serum concentration (Cmax) of CT-P39, EU approved Xolair, and US-licensed Xolair in healthy subjects (CT-P39 to EU approved Xolair, CT-P39 to US licensed Xolair, and EU-approved Xolair to US licensed Xolair)
Timepoint [4] 0 0
up to day 127
Secondary outcome [1] 0 0
Pharmacokinetic Outcome Measures [Tmax] - To assess Time to Cmax (Tmax) of CT-P39, EU-approved Xolair, and US-licensed Xolair in healthy subjects
Timepoint [1] 0 0
up to day 127
Secondary outcome [2] 0 0
Pharmacokinetic Outcome Measures [t1/2] - To assess Terminal half-life (t1/2) of CT-P39, EU-approved Xolair, and US-licensed Xolair in healthy subjects
Timepoint [2] 0 0
up to day 127
Secondary outcome [3] 0 0
Pharmacokinetic Outcome Measures [%AUCext] - To assess Percentage of AUC0-inf obtained by extrapolation (%AUCext) of CT-P39, EU-approved Xolair, and US-licensed Xolair in healthy subjects
Timepoint [3] 0 0
up to day 127
Secondary outcome [4] 0 0
Pharmacokinetic Outcome Measures [?z] - To assess Terminal elimination rate constant (?z) of CT-P39, EU-approved Xolair, and US-licensed Xolair in healthy subjects
Timepoint [4] 0 0
up to day 127
Secondary outcome [5] 0 0
Pharmacokinetic Outcome Measures [Apparent total body clearance (CL/F)] - To assess Apparent total body clearance (CL/F) of CT-P39, EU-approved Xolair, and US-licensed Xolair in healthy subjects
Timepoint [5] 0 0
up to day 127
Secondary outcome [6] 0 0
Pharmacokinetic Outcome Measures [Mean residence time (MRT)] - To assess Mean residence time (MRT) of CT-P39, EU-approved Xolair, and US-licensed Xolair in healthy subjects
Timepoint [6] 0 0
up to day 127
Secondary outcome [7] 0 0
Pharmacodynamics [IgE level] - Free IgE and total IgE levels (the sum of free and omalizumab-bound IgE) in the serum samples from subjects
Timepoint [7] 0 0
up to day 127
Secondary outcome [8] 0 0
Incidence of Adverse events of Special Interest [Safety] - Adverse events of Special Interest (AESI) of CT-P39, 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)
Timepoint [8] 0 0
up to day 127

Eligibility
Key inclusion criteria
- Healthy subject (male or female) between the ages of 18 and 55 years.

- Subject with a body weight of > 40 kg and = 90 kg and a BMI between 18.0 kg/m2 and
29.9 kg/m2(both inclusive).

- Subject with an IgE level of = 100 IU/mL.
Minimum age
18 Years
Maximum age
55 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Subject has a medical history and/or current presence of disease including one or more
of the allergic reaction.

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,SA
Recruitment hospital [1] 0 0
Phase 1 unit - Herston
Recruitment hospital [2] 0 0
Phase 1 unit - Adelaide
Recruitment postcode(s) [1] 0 0
4006 - Herston
Recruitment postcode(s) [2] 0 0
5000 - Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Celltrion
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
A Phase 1, Randomized, Double-blind, Three-arm, Parallel Group, Single-dose Study to Compare
the Pharmacokinetics and Safety of Three Formulations of Omalizumab (CT-P39, EU-approved
Xolair, and US-licensed Xolair) in Healthy Subjects
Trial website
https://clinicaltrials.gov/show/NCT04018313
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
MinJi Ma
Address 0 0
Country 0 0
Phone 0 0
+82328505720
Fax 0 0
Email 0 0
minji.ma@celltrion.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04018313