NCT04018313

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 Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
176

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started May 2020

Longer than P75 for phase_1 healthy

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 9, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 12, 2019

Completed
11 months until next milestone

Study Start

First participant enrolled

May 28, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 27, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2021

Completed
2 years until next milestone

Results Posted

Study results publicly available

May 11, 2023

Completed
Last Updated

May 11, 2023

Status Verified

September 1, 2021

Enrollment Period

10 months

First QC Date

July 9, 2019

Results QC Date

June 30, 2022

Last Update Submit

June 30, 2022

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

  • 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)

    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)

    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)

    up to day 127

Secondary Outcomes (6)

  • Pharmacokinetic Outcome Measures [Tmax] for Part 1& Part 2

    up to day 127

  • Pharmacokinetic Outcome Measures [t1/2] for Part 1& Part 2

    up to day 127

  • Pharmacodynamics Outcome Measures [Cmin of Free IgE] for Part 1 & Part 2

    up to day 127

  • Pharmacodynamic Outcome Measures [Tmin of Free IgE] for Part 1 & Part 2

    Up to day 127

  • Pharmacodynamic Outcome Measures [Cmax of Total IgE] for Part 1 & Part 2

    up to day 127

  • +1 more secondary outcomes

Study Arms (5)

CT-P39 (Part 1)

EXPERIMENTAL

150 mg/mL, Solution for injection in PFS

Biological: CT-P39

EU-approved Xolair (Part 1)

ACTIVE COMPARATOR

150 mg/mL, Solution for injection in PFS

Biological: EU-approved Xolair

CT-P39 (Part 2)

EXPERIMENTAL

150 mg/mL, Solution for injection in PFS

Biological: CT-P39

EU-approved Xolair (Part 2)

ACTIVE COMPARATOR

150 mg/mL, Solution for injection in PFS

Biological: EU-approved Xolair

US-licensed Xolair (Part 2)

ACTIVE COMPARATOR

150 mg/mL, Solution for injection in PFS

Biological: US-licensed Xolair

Interventions

CT-P39BIOLOGICAL

150 mg/mL, Solution for injection in PFS

CT-P39 (Part 1)
EU-approved XolairBIOLOGICAL

150 mg/mL, Solution for injection in PFS

EU-approved Xolair (Part 1)
US-licensed XolairBIOLOGICAL

150 mg/mL, Solution for injection in PFS

US-licensed Xolair (Part 2)

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Phase 1 unit

Herston, Queensland, 4006, Australia

Location

Phase 1 unit

Adelaide, South Australia, 5000, Australia

Location

Results Point of Contact

Title
Keumyoung Ahn/Head of Clinical Planning 2 Department
Organization
Celltrion. Inc
Keumyoung.ahn@celltrion.com
+82 32 850 4190

Study Officials

  • SungHyun Kim

    Celltrion

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2019

First Posted

July 12, 2019

Study Start

May 28, 2020

Primary Completion

March 27, 2021

Study Completion

April 30, 2021

Last Updated

May 11, 2023

Results First Posted

May 11, 2023

Record last verified: 2021-09

Locations

AU(2)