Study to Compare Pharmacokinetics and Safety of CT-P52 and US-licensed Taltz in Healthy Subjects
NCT07200986 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 218
Last updated 2025-12-31
Summary
This study is designed to demonstrate PK similarity of the proposed biosimilar test product CT-P52 and the reference product, US-licensed Taltz.
Conditions
- Healthy Participants
Interventions
- BIOLOGICAL
-
Ixekizumab
80 mg (single dose), SC injection via PFS
Sponsors & Collaborators
- lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 19 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-09-17
- Primary Completion
- 2026-03-31
- Completion
- 2026-03-31
- FDA Drug
- Yes
Countries
- South Korea
Study Locations
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