Study to Compare Pharmacokinetics and Safety of CT-P52 and US-licensed Taltz in Healthy Subjects
NCT ID: NCT07200986
Last Updated: 2025-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1
218 participants
INTERVENTIONAL
2025-09-17
2026-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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CT-P52
80 mg (single dose), subcutaneous (SC) injection via pre-filled syringe (PFS)
Ixekizumab
80 mg (single dose), SC injection via PFS
United States (US)-licensed Taltz
80 mg (single dose), subcutaneous (SC) injection via pre-filled syringe (PFS)
Ixekizumab
80 mg (single dose), SC injection via PFS
Interventions
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Ixekizumab
80 mg (single dose), SC injection via PFS
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
19 Years
55 Years
ALL
Yes
Sponsors
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Celltrion
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Other Identifiers
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CT-P52 1.1
Identifier Type: -
Identifier Source: org_study_id