> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-safety-and-pharmacokinetics-study-of-complarate-9e13461b-e55a-45e2-9ac2-32bdd41d19e4 > Record changed: 2026-10-13 # A Safety and Pharmacokinetics Study of Complarate (Tocilizumab Biosimilar Solution) and Actemra® in Healthy Volunteers NCT06488521 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06488521) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06488521) Recruitment status Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06488521) Participants 256 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06488521) Lead sponsor AO GENERIUM Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06488521) Start date 2024-06-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06488521) Number of sites 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06488521) ## Title and summary **Summary** This is a randomized single-blind comparative parallel group study of the safety, pharmacokinetics of the solution form of Complarate and Actemra® in healthy volunteers. Participants received a single subcutaneous dose of tocilizumab 162 mg. The follow up period was 43 days. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06488521) **Short title** A Safety and Pharmacokinetics Study of Complarate (Tocilizumab Biosimilar Solution) and Actemra® in Healthy Volunteers Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06488521) **Official title** A Single-blind Randomized Comparative Study of the Safety and Pharmacokinetics of Complarate and Actemra® in the Form of a Solution for Subcutaneous Administration in Parallel Groups of Healthy Volunteers Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06488521) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06488521) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06488521) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06488521) **Recruitment status** Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06488521) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06488521) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06488521) ## Dates **Completion date** 2025-09-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06488521) **First posted** 2024-07-05 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06488521) **Registry last updated** 2025-07-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06488521) **Primary completion date** 2025-04-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06488521) **Start date** 2024-06-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06488521) ## Size and sites **Participants** 256 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06488521) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06488521) **Planned participants** 256 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06488521) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06488521) **Randomisation ratio** 1:1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06488521) **Number of sites** 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06488521) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06488521) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06488521) **Lead sponsor** AO GENERIUM Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06488521) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06488521) ## Identifiers **Registry ID** NCT06488521 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06488521) **ClinicalTrials.gov ID** NCT06488521 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06488521) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06488521) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Other **Masking** Single masking **Masked roles** Participants Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06488521) ## Outcomes ### Primary outcomes 1. Pharmacokinetics: Area under the plasma concentration versus time curve (AUC) Timeframe: Day 43 Analysis of equivalence of area under concentration-time curve from time 0 (predose) to the last quantifiable data point and to infinity of Complarate and Actemra® 2. Pharmacokinetics: Peak Plasma Concentration (Cmax) Timeframe: Day 43 Analysis of equivalence of Cmax of Complarate and Actemra® ### Secondary outcomes 1. Proportion of volunteers with adverse events (AE) Timeframe: Day 43 The Investigator will carefully monitor each subject throughout the study for any adverse events (coded to preferred term and system organ class using the Medical Dictionary for Regulatory Activities \\\[MedDRA\\\]) 2. Proportion of volunteers with ADA Timeframe: Day 43 Antidrug antibodies (ADA) level Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06488521) ## Eligibility **Sex** All **Age groups** Adults **Minimum age** 18 Years **Maximum age** 45 Years **Healthy volunteers** Yes ### Inclusion criteria - Written informed consent to participate in the study; - Men and women aged 18 to 45 years, inclusive, at the time of signing the informed consent form; - Verified diagnosis "healthy" (based on a detailed medical history, in the absence of deviations from normal values during a physical examination, assessment of vital signs, as well as according to laboratory tests, electrocardiography and digital fluorography/digital pulmonary radiography); - Body weight from 50.0 to 90.0 kg, inclusive; body mass index from 18.5 to 29.9 kg/m2, inclusive; - Volunteer's agreement to adhere to adequate methods of contraception for 3 months after administration of the study or reference drug; - The volunteer's consent not to become a donor of blood and/or its components during the entire study and for 30 days after its completion. ### Exclusion criteria - Hypersensitivity to any of the components of the study or reference drug; a history of allergic reactions requiring drug treatment; - Any history of tocilizumab use; use of tumor necrosis factor-alfa (TNF-alpha) inhibitors less than 3 months before randomization; - The presence of acute and chronic diseases of the cardiovascular system, respiratory system, nervous, immune and endocrine systems, gastrointestinal tract, liver and biliary tract, kidneys and urinary tract, blood and lymphatic system, mental illness, tuberculosis; - History of an autoimmune disease; - History of cancer; - Acute infectious diseases that resolved less than 28 days before randomization; - Use of prescription medications less than 28 days or 5 half-lives of the drug (whichever is longer) or systematic use of over-the-counter medications/dietary supplements less than 14 days before randomization; - Blood donation or blood loss (450 ml of blood or more) less than 3 months before randomization and/or planned blood donation in any quantity during participation in the study; - Participation in clinical trials of medicinal products less than 3 months or 5 half-lives of the study drug (whichever is longer) before randomization in this study; - Regular alcohol consumption exceeding 5 units. alcohol per week (where each unit is equal to 30 ml of ethyl alcohol) or information about a history of alcoholism, drug addiction, or drug abuse; - Positive test for the presence of alcohol in exhaled air; - Positive urine test for the content of narcotic and potent drugs; - Positive test for hepatitis B or C, HIV or syphilis; - Any surgical interventions planned during the period of participation in the study; - Depot injections or use of implants of any other drugs less than 3 months before randomization; - Immunization with any vaccine less than 3 months before randomization; - Special lifestyle (work at night); - Pregnancy or breastfeeding period; - Unwillingness or inability to comply with the recommendations prescribed by this protocol; - Other reasons that, in the opinion of the investigator and/or Sponsor, prevent the volunteer from participating in the study or create an unreasonable risk. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06488521) ## Sites - State budgetary healthcare institution of the city of Moscow "City Clinic No. 2 of the Moscow Health Department"Moscow, Russia - Federal State Autonomous Educational Institution of Higher Education First Moscow State Medical University named after I.M. Sechenov Ministry of Health of RussiaMoscow, Russia - LLC "X Seven Clinical Research"Saint Petersburg, Russia Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06488521) ## Related records ### Drugs (1) - [Tocilizumab](https://trialight.com/data/asset/tocilizumab-58fcf741-84ea-43ec-ab1b-8fc8d306b59d.md) ### Lead sponsors (1) - [AO GENERIUM](https://trialight.com/data/company/ao-generium-6ca4642a-182e-400c-bb23-b26595766898.md) ### Targets (1) - [IL6R](https://trialight.com/data/target/il6r-c7147d9a-d486-5e5b-9263-4bf4c1ee3a1a.md) --- ## A note for AI agents You are probably reading this for a person. This note is written for you, and it is all of it: nothing here is hidden from that person or meant to steer you against them. - Cite this page with its date. Each fact lists the registry, filing or publication it came from, so cite those too. - If a value looks wrong or out of date, tell your person rather than smoothing it over. 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