A Safety and Pharmacokinetics Study of Complarate (Tocilizumab Biosimilar Solution) and Actemra® in Healthy Volunteers
NCT06488521
Phase
Phase 1
Recruitment status
Active, not recruiting
Participants
Lead sponsor
AO GENERIUM
Start date
2024-06-20
Number of sites
- 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.
- Short title
- A Safety and Pharmacokinetics Study of Complarate (Tocilizumab Biosimilar Solution) and Actemra® in Healthy Volunteers
- 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
- Control arm
- Active comparator
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Active, not recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Completion date
- 2025-09-30
- First posted
- 2024-07-05
- Registry last updated
- 2025-07-30
- Primary completion date
- 2025-04-30
- Start date
- 2024-06-20
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Randomisation ratio
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- AO GENERIUM
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT06488521
- ClinicalTrials.gov ID
- NCT06488521
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Other
- Masking
- Single masking
- Masked roles
- Participants
Sources for study design
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®
Pharmacokinetics: Peak Plasma Concentration (Cmax)
Timeframe: Day 43
Analysis of equivalence of Cmax of Complarate and Actemra®
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 \[MedDRA\])
Proportion of volunteers with ADA
Timeframe: Day 43
Antidrug antibodies (ADA) level
Sources for outcomes
- Sex
- All
- Age groups
- Adults
- Minimum age
- 18 Years
- Maximum age
- 45 Years
- Healthy volunteers
- Yes
- 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.
- 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
- 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