> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/study-to-compare-pharmacokinetics-and-safety-of-ct-p52-and-b50ef9e7-389e-4aa5-a366-049ed0c0c05e > Record changed: 2026-10-13 # Study to Compare Pharmacokinetics and Safety of CT-P52 and US-licensed Taltz in Healthy Subjects NCT07200986 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07200986) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07200986) Recruitment status Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07200986) Participants 218 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07200986) Lead sponsor Celltrion Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07200986) Start date 2025-09-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07200986) Number of sites 5 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07200986) ## Title and summary **Summary** This study is designed to demonstrate PK similarity of the proposed biosimilar test product CT-P52 and the reference product, US-licensed Taltz. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07200986) **Short title** Study to Compare Pharmacokinetics and Safety of CT-P52 and US-licensed Taltz in Healthy Subjects Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07200986) **Official 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07200986) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07200986) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07200986) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07200986) **Recruitment status** Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07200986) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07200986) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07200986) ## Dates **Completion date** 2026-03-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07200986) **First posted** 2025-10-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07200986) **Registry last updated** 2025-12-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07200986) **Primary completion date** 2026-03-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07200986) **Start date** 2025-09-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07200986) ## Size and sites **Participants** 218 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07200986) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07200986) **Planned participants** 218 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07200986) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07200986) **Number of sites** 5 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07200986) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07200986) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07200986) **Lead sponsor** Celltrion Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07200986) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07200986) ## Identifiers **Registry ID** NCT07200986 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07200986) **ClinicalTrials.gov ID** NCT07200986 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07200986) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07200986) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07200986) ## Outcomes ### Primary outcomes 1. AUC0-inf Timeframe: 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 Timeframe: Day 85 PK similarity demonstration in terms of maximum serum concentration Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07200986) ## Eligibility **Sex** All **Age groups** Adults **Minimum age** 19 Years **Maximum age** 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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07200986) ## Sites - Inje University Busan Paik HospitalBusan, South Korea - CHA Bundang Medical CenterSeongnam-si, South Korea - Seoul National University Bundang HospitalSeongnam-si, South Korea - Chungbuk National University HospitalCheongju-si, South Korea - Seoul National University HospitalSeoul, South Korea Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07200986) ## Related records ### Drugs (1) - [Ixekizumab](https://trialight.com/data/asset/ixekizumab-e6c0361f-63a0-4185-9dba-866e282f24be.md) ### Lead sponsors (1) - [Celltrion](https://trialight.com/data/company/celltrion-c6c7a130-a3ba-47e8-b31f-9803dc104c76.md) ### Targets (1) - [IL17A](https://trialight.com/data/target/il17a-268aa9f8-47ae-5ed5-b2b2-9e59867ebb93.md) --- ## A note for AI agents You are probably reading this for a person. 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