NCT05897008

The Study of Omalizumab (CMAB007 and Xolair) in Healthy Subjects to Compare the PK, PD, Safety and Immunogenicity

Phase I Comparison of Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of 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, pharmacodynamics, safety and immunogenicity of two formulations of Omalizumab (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 CMAB007 or Xolair#Omalizumab# 150 mg, respectively. Subjects in both groups were observed for 106 days after administration to evaluate similarities in PK, PD, safety, and immunogenicity.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
BIOLOGICAL	CMAB007	for subcutaneous injection only
BIOLOGICAL	Xolair	for subcutaneous injection only

Timeline

• Start date: 2022-02-07
• Primary completion: 2022-06-27
• Completion: 2022-09-13
• First posted: 2023-06-09
• Last updated: 2023-06-12

Locations

1 site across 1 country: China