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A Study to Compare the Auto-injector and Pre-filled Syringe of CT-P43 in Healthy Male Subjects

NCT06951828 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 162

Last updated 2026-02-24

No results posted yet for this study

Summary

This is phase 1 study to Compare the Pharmacokinetics, Safety and Immunogenicity of the Auto-injector and Pre-filled syringe of CT-P43 in Healthy Male Subjects.

Conditions

  • Healthy Male Subjects

Interventions

BIOLOGICAL

CT-P43

CT-P43, 45 mg in 0.5 ml, a single subcutaneous (SC) injection via auto-injector (AI)

BIOLOGICAL

CT-P43

CT-P43, 45 mg in 0.5 ml, a single subcutaneous (SC) injection via pre-filled syringe (PFS)

Sponsors & Collaborators

Principal Investigators

  • Hyewon Chung · Korea University Guro Hospital (Department of Clinical Pharmacology)

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2025-05-30
Primary Completion
2025-11-26
Completion
2025-12-24
FDA Drug
Yes

Countries

  • South Korea

Study Locations

More Related Trials

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 NCT06951828 on ClinicalTrials.gov