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OpenTrials
Active, Not Recruiting

NCT Number: NCT07200986

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

19 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Inje University Busan Paik Hospital, Busan, Busanjin-gu, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ixekizumab

Biological

80 mg (single dose), SC injection via PFS

Primary outcomes

  1. AUC0-inf

    Time frame: Day 85

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

  2. Cmax

    Time frame: Day 85

    PK similarity demonstration in terms of maximum serum concentration

Sponsors and collaborators

Lead sponsor

Celltrion

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 1, 2025
Registry last updated
Dec 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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