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

> **NCT04018313** · PHASE1 · COMPLETED · sponsor: **Celltrion** · enrollment: 176 (actual)

## Conditions studied

- Healthy

## Interventions

- **BIOLOGICAL:** CT-P39
- **BIOLOGICAL:** EU-approved Xolair
- **BIOLOGICAL:** CT-P39
- **BIOLOGICAL:** EU-approved Xolair
- **BIOLOGICAL:** US-licensed Xolair

## Key facts

- **NCT ID:** NCT04018313
- **Lead sponsor:** Celltrion
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE1
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2020-05-28
- **Primary completion:** 2021-03-27
- **Final completion:** 2021-04-30
- **Target enrollment:** 176 (ACTUAL)
- **Last updated:** 2023-05-11


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT04018313

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT04018313, "To Compare the PK and Safety of Omalizumab (CT-P39, EU-approved Xolair, and US-licensed Xolair) in Healthy Subjects". Retrieved via AI Analytics 2026-06-24 from https://api.ai-analytics.org/clinical/NCT04018313. Licensed CC0.

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