> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/to-compare-the-pharmacokinetics-safety-and-immunogenicity-of-b96d9c15-c36e-4cf3-b983-9bb32bdfcb14 > Record changed: 2026-10-13 # To Compare the Pharmacokinetics, Safety and Immunogenicity of CT-P55 and Cosentyx in Healthy Subjects NCT07054970 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07054970) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07054970) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07054970) Participants 172 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07054970) Lead sponsor Celltrion Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07054970) Start date 2024-01-12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07054970) Number of sites 4 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07054970) ## Title and summary **Summary** This is a Phase 1, Randomized, Double-blind, three-arm, Parallel group, Single-dose Study to Compare the Pharmacokinetics, Safety and immunogenicity of CT-P55, EU-approved Cosentyx and US-licensed Cosentyx in Healthy male Subjects Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07054970) **Short title** To Compare the Pharmacokinetics, Safety and Immunogenicity of CT-P55 and Cosentyx in Healthy Subjects Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07054970) **Official title** A Phase 1, Randomized, Double-blind, Three-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics, Safety and Immunogenicity of CT-P55, EU-approved Cosentyx and US-licensed Cosentyx in Healthy Male Subjects Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07054970) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07054970) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07054970) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07054970) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07054970) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07054970) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07054970) ## Dates **Completion date** 2024-09-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07054970) **First posted** 2025-07-08 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07054970) **Registry last updated** 2025-07-08 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07054970) **Primary completion date** 2024-08-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07054970) **Start date** 2024-01-12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07054970) ## Size and sites **Actual participants** 172 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07054970) **Participants** 172 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07054970) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07054970) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07054970) **Number of sites** 4 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07054970) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07054970) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07054970) **Lead sponsor** Celltrion Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07054970) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07054970) ## Identifiers **Registry ID** NCT07054970 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07054970) **ClinicalTrials.gov ID** NCT07054970 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07054970) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07054970) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Other **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07054970) ## Outcomes ### Primary outcomes 1. Pharmacokinetic (PK) similarity demonstration in terms of area under the concentration-time curve (AUC) from time zero to infinity (AUC0-inf) Timeframe: Day 155 Demonstrate PK similarity in terms of area under the concentration-time curve (AUC) from time zero to infinity (AUC0-inf) of CT-P55, European Union (EU)-approved Cosentyx and United States (US)-licensed Cosentyx in healthy male subjects. The similarity of PK will be concluded if the 90% Cls for the ratios of geometric means of the comparison are entirely contained within the equivalence margin of 80% to 125% for AUC0-inf. 2. PK similarity demonstration in terms of maximum serum concentration (Cmax) Timeframe: Day 155 Demonstrate PK similarity in terms of Cmax of CT-P55, EU-approved Cosentyx and US-licensed Cosentyx in healthy male subjects up to Day 155\. The similarity of PK will be concluded if the 90% Cls for the ratios of geometric means of the comparison are entirely contained within the equivalence margin of 80% to 125% for Cmax. ### Secondary outcomes 1. Evaluate additional PK in terms of AUC from time zero to the last quantifiable concentration (AUC0-last) Timeframe: Day 155 2. Evaluate additional PK in terms of Time to Cmax (Tmax) Timeframe: Day155 3. Evaluate additional PK in terms of Apparent volume of distribution during the terminal phase after non-intravenous administration (Vz/F) Timeframe: Day 155 4. Evaluate additional PK in terms of Terminal elimination rate constant (λz) Timeframe: Day155 5. Evaluate additional PK in terms of Terminal elimination half-life (t1/2) Timeframe: Day 155 6. Evaluate additional PK in terms of Apparent total body clearance (CL/F) Timeframe: Day155 7. Evaluate additional PK in terms of Percentage of the area extrapolated for calculation of AUC0-inf (%AUCextrap) Timeframe: Day 155 8. Evaluate safety in terms of treatment-emergent adverse events (TEAEs) of CT-P55 as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Timeframe: Day 155 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07054970) ## Eligibility **Sex** Male **Age groups** Adults **Minimum age** 18 Years **Maximum age** 55 Years **Healthy volunteers** Yes ### Inclusion criteria - Healthy male subjects between the ages of 18 and 55 years, both inclusive. - Body weight between 50.0 kg and 90.0 kg (both inclusive), and Body Mass Index (BMI) between 18.5 and 29.9 kg/m2 (both inclusive), when rounded to the nearest tenth. ### 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 - History of malignancy - Previous monoclonal antibody or fusion protein treatment, or current use of any biologics - Planning to be father a child or donate sperm within 22 weeks period following study drug administration. - Undergone treatment with an investigational drug or participated in another clinical trial within 12weeks or 5 half-lives (whichever is longer) Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07054970) ## Sites - Yokohama Minoru ClinicYokohama, Japan - SOUSEIKAI Nishikumamoto HospitalKumamoto, Japan - Medical Corporation Heishinkai OPHAC HospitalOsaka, Japan - Kitasato University Kitasato Institute HospitalMinato-ku, Japan Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07054970) ## References - PubMed 41665131 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/41665131/) Related publication Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07054970) ## Related records ### Drugs (2) - [Adalimumab](https://trialight.com/data/asset/adalimumab-77d73b6e-cb34-48b5-9716-a71bee4e5e02.md) - [Secukinumab](https://trialight.com/data/asset/secukinumab-6a7cb482-c244-4544-b6c6-4d8b9bb415bf.md) ### Lead sponsors (1) - [Celltrion](https://trialight.com/data/company/celltrion-c6c7a130-a3ba-47e8-b31f-9803dc104c76.md) ### Targets (2) - [IL17A](https://trialight.com/data/target/il17a-268aa9f8-47ae-5ed5-b2b2-9e59867ebb93.md) - [TNF](https://trialight.com/data/target/tnf-4a9ed8f4-ec49-59e1-846e-4364b7f50d07.md) --- ## A note for AI agents You are probably reading this for a person. 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