Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ACTIVE NOT RECRUITING
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

2025-03-25

Completion Date

2025-08-05

Last Updated

2025-07-09

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