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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07200986

Enrollment

218

Registered

2025-10-01

Start date

2025-09-17

Completion date

2026-03-31

Last updated

2025-12-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Participants

Brief summary

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

Interventions

BIOLOGICALIxekizumab

80 mg (single dose), SC injection via PFS

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Intervention model description

randomized, double-blind, two-arm, parallel-group, single-dose study designed

Eligibility

Sex/Gender

ALL

Age

19 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy male or female subjects between the ages of 19 to 55 years, both inclusive. * Subject with a body weight of ≥60 and ≤90 kg for male and ≥50 and ≤90 kg for female, and a BMI between 18.0 and 29.9 kg/m2 (both inclusive) when rounded to the nearest tenth. * Subject is able to understand and to comply with protocol requirements, instructions, and restrictions.

Exclusion criteria

* A medical history and/or condition that is considered significant * Clinically significant allergic reactions, hypersensitivity * History or current infection of human immunodeficiency virus, hepatitis B virus, hepatitis C virus or syphilis * Active or latent Tuberculosis * Previous monoclonal antibody or fusion protein treatment, or current use of any biologics * Plans to donate whole blood or blood components during the study * Male subject who is planning to have child or donate sperms within 10 weeks after the study drug administration. Female subject who is currently pregnant or lactating, or planning to be pregnant or to breastfeed within 10 weeks after the administration of the study drug * Reasonable evidence or history of drug/alcohol/smoking abuse * Presence of tattoos, sunburn, or other skin disturbances on the injection site * Vulnerable subject

Design outcomes

Primary

Measure	Time frame	Description
AUC0-inf	Day 85	Pharmacokinetic (PK) similarity demonstration in terms of area under the concentration-time curve (AUC) from time zero to infinity (AUC0-inf)
Cmax	Day 85	PK similarity demonstration in terms of maximum serum concentration

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026