NCT07246252

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

Phase I Comparison of Pharmacokinetics, Safety, and Immunogenicity of Process-Changed CMAB007 and Xolair in a Randomized, Double-blind, Parallel Controlled, Single-dose Study in Healthy Chinese Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 114 (actual)
• Sponsor: Taizhou Mabtech Pharmaceutical Co.,Ltd · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed description

This is a randomized, double-blind, parallel-controlled, single-dose phase I clinical study in healthy Chinese male subjects. A total of 114 subjects were planned to be enrolled and randomly assigned to the test group or the control group in a 1:1 ratio. Subjects in both groups received a single subcutaneous injection of Process-Changed CMAB007 or Xolair(Omalizumab) 150 mg, respectively. Subjects in both groups were observed for 106 days after administration to evaluate similarities in PK, safety, and immunogenicity.

Conditions

• Healthy Volunteers (HV)

Interventions

Type	Name	Description
BIOLOGICAL	Process-Changed CMAB007	for subcutaneous injection only
BIOLOGICAL	Xolair (omalizumab)	for subcutaneous injection only

Timeline

• Start date: 2024-03-28
• Primary completion: 2024-09-30
• Completion: 2024-12-02
• First posted: 2025-11-24
• Last updated: 2025-11-24

Locations

1 site across 1 country: China