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

NCT06687928 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-04-23

No results posted yet for this study

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

Conditions

  • Healthy

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

Sponsors & Collaborators

Principal Investigators

  • Minji Ma · Celltrion, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-03-26
Primary Completion
2025-08-05
Completion
2025-08-05

Countries

  • South Korea

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06687928 on ClinicalTrials.gov