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COMPLETED
NCT06687928
PHASE1

To Compare the Pharmacokinetics, Safety, and Immunogenicity of Subcutaneous CT-P6 and Herceptin in Healthy Male Subjects (Trastuzumab)

Sponsor: Celltrion

View on ClinicalTrials.gov

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

2025-03-26

Completion Date

2025-08-05

Last Updated

2026-04-23

Healthy Volunteers

Yes

Conditions

Interventions

BIOLOGICAL

CT-P6 SC

A single fixed dose (600 mg) of CT-P6 subcutaneous

BIOLOGICAL

EU-Approved Herceptin SC

A single fixed dose (600 mg) of EU-approved Herceptin subcutaneous

Locations (1)

Celltrion

Yeonsu-gu, Incheon, South Korea