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

Sponsor
Taizhou Mabtech Pharmaceutical Co.,Ltd
Study ID
NCT07246252
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Volunteers (HV)

Eligibility Criteria

Sex
MALE
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • Process-Changed CMAB007 — BIOLOGICAL
    for subcutaneous injection only
  • Xolair (omalizumab) — BIOLOGICAL
    for subcutaneous injection only

Study Details

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.

Key Dates

Start date
Mar 28, 2024
Status verified
Nov 2025
Primary completion
Sep 30, 2024
Completion
Dec 2, 2024

Study Design

Enrollment
114 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Process-Changed CMAB007
    150 mg Subcutaneous injection
  • Active Comparator: Xolair
    150 mg Subcutaneous injection

Primary Outcome Measure

Area Under the Plasma Concentration-time Curve From Zero (0) Hours Extrapolated to infinite time [ Time Frame: up to 2520 hours ]

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