Trials / Active Not Recruiting
Active Not RecruitingNCT07200986
Study to Compare Pharmacokinetics and Safety of CT-P52 and US-licensed Taltz in Healthy Subjects
A Phase 1, Randomized, Double-blind, Two-arm, Parallel-Group, Single-dose Study to Compare Pharmacokinetics and Safety of CT-P52 and US-licensed Taltz in Healthy Subjects
- Status
- Active Not Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 218 (estimated)
- Sponsor
- Celltrion · Industry
- Sex
- All
- Age
- 19 Years – 55 Years
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Ixekizumab | 80 mg (single dose), SC injection via PFS |
Timeline
- Start date
- 2025-09-17
- Primary completion
- 2026-03-31
- Completion
- 2026-03-31
- First posted
- 2025-10-01
- Last updated
- 2025-12-31
Locations
5 sites across 1 country: South Korea
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07200986. Inclusion in this directory is not an endorsement.