HealthyPhase 1NCT04018313

To Compare the PK and Safety of Omalizumab (CT-P39, EU-approved Xolair, and US-licensed Xolair) in Healthy Subjects

A Phase 1 study testing CT-P39, EU-approved Xolair and US-licensed Xolair in people with Healthy, run by Celltrion at 2 sites in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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 Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: CT-P39, EU-approved Xolair and US-licensed Xolair
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 176 participants
Where: 2 sitesAustralia
Study dates: 28 May 2020to 30 Apr 2021
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

Subject has a medical history and/or current presence of disease including one or more of the allergic reaction.

Trial locations and contacts

2 sites in 1 country.

Australia2 sites

Phase 1 unit
Adelaide, South Australia, 5000
Phase 1 unit
Herston, Queensland, 4006

Other trials in Australia

About this study

Official 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

Conditions: Healthy
Being tested: CT-P39, EU-approved Xolair, US-licensed Xolair

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CT-P39Biological
150 mg/mL, Solution for injection in PFS
EU-approved XolairBiological
150 mg/mL, Solution for injection in PFS
CT-P39Biological
150 mg/mL, Solution for injection in PFS
EU-approved XolairBiological
150 mg/mL, Solution for injection in PFS
US-licensed XolairBiological
150 mg/mL, Solution for injection in PFS

Study groups in NCT04018313
Study group	Role	What they receive
CT-P39 (Part 1)	Experimental	150 mg/mL, Solution for injection in PFS Receives: Biological: CT-P39
EU-approved Xolair (Part 1)	Active comparator	150 mg/mL, Solution for injection in PFS Receives: Biological: EU-approved Xolair
CT-P39 (Part 2)	Experimental	150 mg/mL, Solution for injection in PFS Receives: Biological: CT-P39
EU-approved Xolair (Part 2)	Active comparator	150 mg/mL, Solution for injection in PFS Receives: Biological: EU-approved Xolair
US-licensed Xolair (Part 2)	Active comparator	150 mg/mL, Solution for injection in PFS Receives: Biological: US-licensed Xolair

What is being measured

The primary outcome is the main question the study is designed to answer.

Pharmacokinetic Outcome Measures [AUC0-inf] for Part 2
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)
Measured: up to day 127
Pharmacokinetic Outcome Measures [AUC0-last] for Part 2
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)
Measured: up to day 127
Pharmacokinetic Outcome Measures [Cmax] for Part 2
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)
Measured: up to day 127

Secondary outcomes (6)

Pharmacokinetic Outcome Measures [Tmax] for Part 1& Part 2
To assess Time to Cmax (Tmax) of CT-P39, EU-approved Xolair, and US-licensed Xolair in healthy subjects
Measured: up to day 127
Pharmacokinetic Outcome Measures [t1/2] for Part 1& Part 2
To assess Terminal half-life (t1/2) of CT-P39, EU-approved Xolair, and US-licensed Xolair in healthy subjects
Measured: up to day 127
Pharmacodynamics Outcome Measures [Cmin of Free IgE] for Part 1 & Part 2
To assess the minimum observed concentration (Cmin) of Free IgE in CT-P39, EU-approved Xolair, and US-licensed Xolair in healthy subjects
Measured: up to day 127
Pharmacodynamic Outcome Measures [Tmin of Free IgE] for Part 1 & Part 2
To assess the Time to Cmin (Tmin) of Free IgE in CT-P39, EU-approved Xolair, and US-licensed Xolair in healthy subjects
Measured: Up to day 127
Pharmacodynamic Outcome Measures [Cmax of Total IgE] for Part 1 & Part 2
To assess the maximum observed concentration (Cmax) of total IgE in CT-P39, EU-approved Xolair, and US-licensed Xolair in healthy subjects
Measured: up to day 127
Pharmacodynamic Outcome Measures [Tmax of Total IgE] for Part 1 & Part 2
To assess the Time to Cmax (Tmax) of total IgE in CT-P39, EU-approved Xolair, and US-licensed Xolair in healthy subjects
Measured: up to day 127

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 May 202030 Apr 2021

First posted12 Jul 2019
Study start28 May 2020
Primary completion27 Mar 2021
Study completion30 Apr 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 176 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04018313
Sponsor's protocol ID: CT-P39 1.1
Status last verified: Sep 2021
First submitted: 9 Jul 2019
Last updated: 11 May 2023
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official 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
ClinicalTrials.gov ID: NCT04018313
Acronym / sponsor ID: CT-P39 1.1
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 176 participants (actual)
Lead sponsor: CelltrionIndustry (pharma, biotech, devices)
Study start: 28 May 2020 (actual)
Primary completion: 27 Mar 2021 (actual)
Study completion: 30 Apr 2021 (actual)
First posted: 12 Jul 2019 (actual)
Results: Posted 11 May 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 5

Arm	Type	Receives
CT-P39 (Part 1)	Experimental	Biological: CT-P39150 mg/mL, Solution for injection in PFS
EU-approved Xolair (Part 1)	Active comparator	Biological: EU-approved Xolair150 mg/mL, Solution for injection in PFS
CT-P39 (Part 2)	Experimental	Biological: CT-P39150 mg/mL, Solution for injection in PFS
EU-approved Xolair (Part 2)	Active comparator	Biological: EU-approved Xolair150 mg/mL, Solution for injection in PFS
US-licensed Xolair (Part 2)	Active comparator	Biological: US-licensed Xolair150 mg/mL, Solution for injection in PFS

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (1 listed)

Subject has a medical history and/or current presence of disease including one or more of the allergic reaction.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CT-P39150 mg/mL, Solution for injection in PFS	Biological	CT-P39 (Part 1)
EU-approved Xolair150 mg/mL, Solution for injection in PFS	Biological	EU-approved Xolair (Part 1)
CT-P39150 mg/mL, Solution for injection in PFS	Biological	CT-P39 (Part 2)
EU-approved Xolair150 mg/mL, Solution for injection in PFS	Biological	EU-approved Xolair (Part 2)
US-licensed Xolair150 mg/mL, Solution for injection in PFS	Biological	US-licensed Xolair (Part 2)

Primary outcome

Pharmacokinetic Outcome Measures [AUC0-inf] for Part 2
Time frame: up to day 127
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)
Pharmacokinetic Outcome Measures [AUC0-last] for Part 2
Time frame: up to day 127
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)
Pharmacokinetic Outcome Measures [Cmax] for Part 2
Time frame: up to day 127
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)

6 secondary outcomes

Pharmacokinetic Outcome Measures [Tmax] for Part 1& Part 2
Time frame: up to day 127
Pharmacokinetic Outcome Measures [t1/2] for Part 1& Part 2
Time frame: up to day 127
Pharmacodynamics Outcome Measures [Cmin of Free IgE] for Part 1 & Part 2
Time frame: up to day 127
Pharmacodynamic Outcome Measures [Tmin of Free IgE] for Part 1 & Part 2
Time frame: Up to day 127
Pharmacodynamic Outcome Measures [Cmax of Total IgE] for Part 1 & Part 2
Time frame: up to day 127
Pharmacodynamic Outcome Measures [Tmax of Total IgE] for Part 1 & Part 2
Time frame: up to day 127

Results and safety

Results posted to the registry on 11 May 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CT-P39 (Part 1)	15	14
EU-approved Xolair (Part 1)	15	14
CT-P39 (Part 2)	47	46
EU-approved Xolair (Part 2)	49	47
US-licensed Xolair (Part 2)	50	49

Primary outcome: Pharmacokinetic Outcome Measures [AUC0-inf] for Part 2

Time frame: up to day 127. Mean (Standard Deviation). Unit: day*μg/mL

Measure	CT-P39 (Part 2) n = 46	EU-approved Xolair (Part 2) n = 49	US-licensed Xolair (Part 2) n = 50
Value	910.9 (278.57)	897.7 (270.25)	926.3 (273.30)

CT-P39 (Part 2) vs EU-approved Xolair (Part 2): Ratio of geometric least square means: 105.62 (90% CI 95.91 to 116.31)
CT-P39 (Part 2) vs US-licensed Xolair (Part 2): Ratio of geometric least square means: 98.72 (90% CI 89.76 to 108.58)
EU-approved Xolair (Part 2) vs US-licensed Xolair (Part 2): Ratio of geometric least square means: 93.47 (90% CI 85.09 to 102.68)

Population analysed: PK set: all randomly assigned subjects who receive a complete dose of study drug and provide at least one post-treatment serum concentration above the lower limit of quantification for omalizumab.

Primary outcome: Pharmacokinetic Outcome Measures [AUC0-last] for Part 2

Time frame: up to day 127. Mean (Standard Deviation). Unit: day*μg/mL

Measure	CT-P39 (Part 2) n = 47	EU-approved Xolair (Part 2) n = 49	US-licensed Xolair (Part 2) n = 50
Value	846 (251.87)	843.8 (248.04)	850.0 (213.13)

CT-P39 (Part 2) vs EU-approved Xolair (Part 2): Ratio of geometric least square means: 104.00 (90% CI 94.96 to 113.89)
CT-P39 (Part 2) vs US-licensed Xolair (Part 2): Ratio of geometric least square means: 99.30 (90% CI 90.79 to 108.61)
EU-approved Xolair (Part 2) vs US-licensed Xolair (Part 2): Ratio of geometric least square means: 95.48 (90% CI 87.36 to 104.37)

Primary outcome: Pharmacokinetic Outcome Measures [Cmax] for Part 2

Time frame: up to day 127. Mean (Standard Deviation). Unit: μg/mL

Measure	CT-P39 (Part 2) n = 47	EU-approved Xolair (Part 2) n = 49	US-licensed Xolair (Part 2) n = 50
Value	20.08 (5.9940)	18.24 (4.9981)	19.43 (5.4159)

CT-P39 (Part 2) vs EU-approved Xolair (Part 2): Ratio of geometric least square means: 113.14 (90% CI 103.15 to 124.11)
CT-P39 (Part 2) vs US-licensed Xolair (Part 2): Ratio of geometric least square means: 103.88 (90% CI 94.83 to 113.80)
EU-approved Xolair (Part 2) vs US-licensed Xolair (Part 2): Ratio of geometric least square means: 91.82 (90% CI 83.87 to 100.52)

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: All AEs were collected from the date the ICF was signed and AE reporting continued until the end of the subject's participation in this study (up to Day 127).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CT-P39 (Part 1)	0 of 15 (0%)	4 of 15 (26.7%)	0 of 15
EU-approved Xolair (Part 1)	0 of 15 (0%)	7 of 15 (46.7%)	0 of 15
CT-P39 (Part 2)	1 of 47 (2.1%)	20 of 47 (42.6%)	0 of 47
EU-approved Xolair (Part 2)	0 of 49 (0%)	26 of 49 (53.1%)	0 of 49
US-licensed Xolair (Part 2)	0 of 50 (0%)	31 of 50 (62%)	0 of 50

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

SungHyun Kim study director

Celltrion

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CT-P39, EU-approved Xolair and US-licensed Xolair in people with Healthy, run by Celltrion at 2 sites in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pharmacokinetic Outcome Measures [AUC0-inf] for Part 2 (time frame: up to day 127). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04018313.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2023.