Study to Compare Pharmacokinetics and Safety of CT-P52 and US-licensed Taltz in Healthy Subjects

Sponsor
Celltrion
Study ID
NCT07200986
Phase
PHASE1
Status
Active Not Recruiting

Conditions

  • Healthy Participants

Eligibility Criteria

Sex
ALL
Age
19 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Ixekizumab — BIOLOGICAL
    80 mg (single dose), SC injection via PFS

Study Details

This study is designed to demonstrate PK similarity of the proposed biosimilar test product CT-P52 and the reference product, US-licensed Taltz.

Key Dates

First listed
Oct 1, 2025
Start date
Sep 17, 2025
Status verified
Dec 2025
Primary completion
Mar 31, 2026
Completion
Mar 31, 2026

Study Design

Enrollment
218 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: CT-P52
    80 mg (single dose), subcutaneous (SC) injection via pre-filled syringe (PFS)
  • Active Comparator: United States (US)-licensed Taltz
    80 mg (single dose), subcutaneous (SC) injection via pre-filled syringe (PFS)

Primary Outcome Measure

AUC0-inf [ Time Frame: Day 85 ]

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