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

NCT04018313 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 176

Last updated 2023-05-11

Study results available
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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

Conditions

  • Healthy

Interventions

BIOLOGICAL

CT-P39

150 mg/mL, Solution for injection in PFS

BIOLOGICAL

EU-approved Xolair

150 mg/mL, Solution for injection in PFS

BIOLOGICAL

CT-P39

150 mg/mL, Solution for injection in PFS

BIOLOGICAL

EU-approved Xolair

150 mg/mL, Solution for injection in PFS

BIOLOGICAL

US-licensed Xolair

150 mg/mL, Solution for injection in PFS

Sponsors & Collaborators

Principal Investigators

  • SungHyun Kim · Celltrion

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-05-28
Primary Completion
2021-03-27
Completion
2021-04-30

Countries

  • Australia

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04018313 on ClinicalTrials.gov