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

NCT07200986 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: CT-P52 1.1
• Study Type: interventional
• Target: 218
• Locations: 1 country
• Sites: 5

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.

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (2)

• AUC0-inf

  Pharmacokinetic (PK) similarity demonstration in terms of area under the concentration-time curve (AUC) from time zero to infinity (AUC0-inf)

  Day 85

• Cmax

  PK similarity demonstration in terms of maximum serum concentration

  Day 85

Study Arms (2)

CT-P52

EXPERIMENTAL

80 mg (single dose), subcutaneous (SC) injection via pre-filled syringe (PFS)

Biological: Ixekizumab

United States (US)-licensed Taltz

ACTIVE COMPARATOR

80 mg (single dose), subcutaneous (SC) injection via pre-filled syringe (PFS)

Biological: Ixekizumab

Interventions

Ixekizumab BIOLOGICAL

80 mg (single dose), SC injection via PFS

CT-P52; United States (US)-licensed Taltz

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Celltrion: lead

Study Sites (5)

Inje University Busan Paik Hospital

Busan, Busanjin-gu, South Korea

Location

CHA Bundang Medical Center

Seongnam-si, Gyeonggi-do, South Korea

Location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Location

Chungbuk National University Hospital

Cheongju-si, North Chungcheong, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Interventions

ixekizumab

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: September 23, 2025
• First Posted: October 1, 2025
• Study Start: September 17, 2025
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: December 31, 2025

Record last verified: 2025-12

Locations

KR (5)