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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04018313




Registration number
NCT04018313
Ethics application status
Date submitted
9/07/2019
Date registered
12/07/2019
Date last updated
11/05/2023

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
Pharmacokinetic Outcome Measures [AUC0-inf] for Part 2
Timepoint [1] 0 0
up to day 127
Primary outcome [2] 0 0
Pharmacokinetic Outcome Measures [AUC0-last] for Part 2
Timepoint [2] 0 0
up to day 127
Primary outcome [3] 0 0
Pharmacokinetic Outcome Measures [Cmax] for Part 2
Timepoint [3] 0 0
up to day 127
Secondary outcome [1] 0 0
Pharmacokinetic Outcome Measures [Tmax] for Part 1& Part 2
Timepoint [1] 0 0
up to day 127
Secondary outcome [2] 0 0
Pharmacokinetic Outcome Measures [t1/2] for Part 1& Part 2
Timepoint [2] 0 0
up to day 127
Secondary outcome [3] 0 0
Pharmacodynamics Outcome Measures [Cmin of Free IgE] for Part 1 & Part 2
Timepoint [3] 0 0
up to day 127
Secondary outcome [4] 0 0
Pharmacodynamic Outcome Measures [Tmin of Free IgE] for Part 1 & Part 2
Timepoint [4] 0 0
Up to day 127
Secondary outcome [5] 0 0
Pharmacodynamic Outcome Measures [Cmax of Total IgE] for Part 1 & Part 2
Timepoint [5] 0 0
up to day 127
Secondary outcome [6] 0 0
Pharmacodynamic Outcome Measures [Tmax of Total IgE] for Part 1 & Part 2
Timepoint [6] 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
32.0 kg/m2(both inclusive).

- Subject with a total IgE level of = 100 IU/mL.
Minimum age
18 Years
Maximum age
55 Years
Sex
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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/05/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/04/2021
Sample size
Target
Accrual to date
Final
176
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/ct2/show/NCT04018313
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
SungHyun Kim
Address 0 0
Celltrion
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04018313