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To Compare the Pharmacokinetics, Safety and Immunogenicity of CT-P55 and Cosentyx in Healthy Subjects

NCT07054970 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 172

Last updated 2025-07-08

No results posted yet for this study

Summary

This is a Phase 1, Randomized, Double-blind, three-arm, Parallel group, Single-dose Study to Compare the Pharmacokinetics, Safety and immunogenicity of CT-P55, EU-approved Cosentyx and US-licensed Cosentyx in Healthy male Subjects

Conditions

  • Healthy Male Subjects

Interventions

BIOLOGICAL

CT-P55

150 mg in 1.0 mL, administered as a single SC injection via PFS

BIOLOGICAL

US-licensed Cosentyx

150 mg in 1.0 mL, administered as a single SC injection via PFS

BIOLOGICAL

EU-approved Cosentyx

150 mg in 1.0 mL, administered as a single SC injection via PFS

Sponsors & Collaborators

Principal Investigators

  • Tomoko Hasunuma · Kitasato University Kitasato Institute Hospital

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2024-01-12
Primary Completion
2024-08-29
Completion
2024-09-06

Countries

  • Japan

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 NCT07054970 on ClinicalTrials.gov