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To Compare the Pharmacokinetics, Safety, and Immunogenicity of Subcutaneous CT-P6 and Herceptin in Healthy Male Subjects (Trastuzumab)
Sponsor: Celltrion
Summary
A Randomized, Double-blind, Two-arm, Parallel-group, Single-dose, Phase 1 Study to Compare the Pharmacokinetics, Safety, and Immunogenicity of Subcutaneous CT-P6 and Herceptin in Healthy Male Subjects
Official title: A Randomized, Double-blind, Two-arm, Parallel-group, Single-dose, Phase 1 Study to Compare the Pharmacokinetics, Safety, and Immunogenicity of Subcutaneous CT-P6 and Herceptin in Healthy Male Subjects
Key Details
Gender
MALE
Age Range
19 Years - 55 Years
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2025-03-25
Completion Date
2025-08-05
Last Updated
2025-07-09
Healthy Volunteers
Yes
Conditions
Interventions
CT-P6 SC
A single fixed dose (600 mg) of CT-P6 subcutaneous
EU-Approved Herceptin SC
A single fixed dose (600 mg) of EU-approved Herceptin subcutaneous
Locations (1)
Celltrion
Yeonsu-gu, Incheon, South Korea