> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-to-compare-the-pharmacokinetics-and-safety-of-ct-p47-dcd68c5b-587a-48a8-a7ec-866322d0e96b > Record changed: 2026-10-13 # A Study to Compare the Pharmacokinetics and Safety of CT-P47 and RoActemra in Healthy Subjects NCT05188378 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05188378) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05188378) Recruitment status Unknown Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05188378) Participants 300 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05188378) Lead sponsor Celltrion Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05188378) Start date 2021-12-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05188378) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05188378) ## Title and summary **Summary** A study to Compare the Pharmacokinetics and Safety of CT-P47 and RoActemra in Healthy Subjects Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05188378) **Short title** A Study to Compare the Pharmacokinetics and Safety of CT-P47 and RoActemra in Healthy Subjects Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05188378) **Official title** A Phase 1, Randomized, Double-blind, Two-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics and Safety of Two Subcutaneous Injection Formulations of Tocilizumab (CT-P47 and EU-approved RoActemra) in Healthy Subjects Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05188378) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05188378) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05188378) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05188378) **Recruitment status** Unknown Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05188378) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05188378) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05188378) ## Dates **Completion date** 2023-01-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05188378) **First posted** 2022-01-12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05188378) **Registry last updated** 2022-01-12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05188378) **Primary completion date** 2022-10-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05188378) **Start date** 2021-12-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05188378) ## Size and sites **Participants** 300 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05188378) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05188378) **Planned participants** 300 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05188378) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05188378) **Randomisation ratio** 1:1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05188378) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05188378) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05188378) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05188378) **Lead sponsor** Celltrion Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05188378) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05188378) ## Identifiers **Registry ID** NCT05188378 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05188378) **ClinicalTrials.gov ID** NCT05188378 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05188378) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05188378) ## 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/NCT05188378) ## Outcomes ### Primary outcomes 1. Primary objective Timeframe: up to Day 43 To demonstrate PK similarity in terms of Area under the zero to infinity (AUC0-inf) 2. Primary objective Timeframe: up to Day 43 To demonstrate PK similarity in terms of Area under the concentration-time curve from time zero to the last quantifiable concentration (AUC0-last) 3. Primary objective Timeframe: up to Day 43 To demonstrate PK similarity in terms of Maximum serum concentration (Cmax) Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05188378) ## Eligibility **Sex** All **Age groups** Adults **Minimum age** 19 Years **Maximum age** 55 Years **Healthy volunteers** Yes ### Inclusion criteria - Healthy subjects - Body weight of ≥60 and ≤100 kg for male and ≥50 and ≤100 kg for female and a BMI between 18.5 and 28.0 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 hepatitis B virus, hepatitis C virus, human immunodeficiency virus, or syphilis - Active or latent Tuberculosis - History of malignancy - Previous exposure to tocilizumab or any drug that targets IL-6 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05188378) ## Sites - Seoul National University HospitalSeoul, South KoreaRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05188378) ## References - PubMed 37231670 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/37231670/) Related publication Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05188378) ## Related records ### Drugs (1) - [Adalimumab](https://trialight.com/data/asset/adalimumab-77d73b6e-cb34-48b5-9716-a71bee4e5e02.md) ### Lead sponsors (1) - [Celltrion](https://trialight.com/data/company/celltrion-c6c7a130-a3ba-47e8-b31f-9803dc104c76.md) ### Targets (1) - [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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