CClinicalTrials.gg
Sign In
Active, not recruitingNCT07200986Updated Dec 31, 2025

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

A Phase 1 interventional study of Ixekizumab in Healthy Participants, sponsored by Celltrion. Active, not recruiting at 5 sites in South Korea. Open to participants aged 19 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-31.

Sponsored by Celltrion · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Mar 2026, 6 months ago, but the record still lists the study as active, not recruiting.
Phase
Phase 1
Study type
Interventional
Enrollment
218
Allocation
Randomized
Ages
19 Years to 55 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Healthy Participants
03

In context

Lead sponsor

Celltrion is the lead sponsor of 76 studies on the registry; 3 are open to participants now.

Of its 18 completed or terminated interventional studies of FDA-regulated products, 13 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 55 Years
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
218 participants (estimated)

Study arms

  • Experimental
    CT-P52

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

    Biological: Ixekizumab

  • Active comparator
    United States (US)-licensed Taltz

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

    Biological: Ixekizumab

Interventions

  • BiologicalIxekizumab

    80 mg (single dose), SC injection via PFS

06

What researchers measure

Primary outcomes

  1. AUC0-inf

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

    Time frame: Day 85

  2. Cmax

    PK similarity demonstration in terms of maximum serum concentration

    Time frame: Day 85

07

Study locations

5 sites
  • Inje University Busan Paik Hospital
    Busan, Busanjin-gu, South Korea
  • CHA Bundang Medical Center
    Seongnam-si, Gyeonggi-do, South Korea
  • Seoul National University Bundang Hospital
    Seongnam-si, Gyeonggi-do, South Korea
  • Chungbuk National University Hospital
    Cheongju-si, North Chungcheong, South Korea
  • Seoul National University Hospital
    Seoul, South Korea
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 31, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07200986
Lead sponsor
Celltrion
Responsible party
Sponsor
First posted
Oct 1, 2025
Start date
Sep 17, 2025
Primary completion
Mar 31, 2026 (estimated)
Completion
Mar 31, 2026 (estimated)
Last update
Dec 31, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Celltrion

Start the discussion