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Compare the PK, Safety, and Immunogenicity of Process-Changed CMAB007 and Xolair in Healthy Adult Male Subjects

NCT07246252 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 114

Last updated 2025-11-24

No results posted yet for this study

Summary

A phase 1, randomized, double-blind, parallel group, single-dose study to compare the pharmacokinetics, safety and immunogenicity of two formulations of Omalizumab (Process-Changed CMAB007 and Xolair) in healthy subjects.

Conditions

  • Healthy Volunteers (HV)

Interventions

BIOLOGICAL

Process-Changed CMAB007

for subcutaneous injection only

BIOLOGICAL

Xolair (omalizumab)

for subcutaneous injection only

Sponsors & Collaborators

  • Taizhou Mabtech Pharmaceutical Co.,Ltd

    lead INDUSTRY

Principal Investigators

  • Jingying Jia, Ph.D · Shanghai Xuhui Central Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-03-28
Primary Completion
2024-09-30
Completion
2024-12-02

Countries

  • China

Study Locations

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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 NCT07246252 on ClinicalTrials.gov