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

Sponsor
Celltrion
Study ID
NCT07054970
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Male Subjects

Eligibility Criteria

Sex
MALE
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • CT-P55 — BIOLOGICAL
    150 mg in 1.0 mL, administered as a single SC injection via PFS
  • US-licensed Cosentyx — BIOLOGICAL
    150 mg in 1.0 mL, administered as a single SC injection via PFS
  • EU-approved Cosentyx — BIOLOGICAL
    150 mg in 1.0 mL, administered as a single SC injection via PFS

Study Details

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

Key Dates

Start date
Jan 12, 2024
Status verified
Jul 2025
Primary completion
Aug 29, 2024
Completion
Sep 6, 2024

Study Design

Enrollment
172 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: CT-P55
    a single subcutaneous (SC) injection via pre-filled syringe (PFS)
  • Active Comparator: US-licensed Cosentyx
    a single SC injection via PFS
  • Active Comparator: EU-approved Cosentyx
    a single SC injection via PFS

Primary Outcome Measure

Pharmacokinetic (PK) similarity demonstration in terms of area under the concentration-time curve (AUC) from time zero to infinity (AUC0-inf) [ Time Frame: Day 155 ]