A Single-blind Randomized Parallel-group Comparative Study of the Pharmacokinetics, Pharmacodynamics, Safety and Immunogenicity of GNR-086 and Ilaris® After a Single Subcutaneous Administration to Healthy Volunteers at a Dose of 150 mg

CAN-HVL-I

This is a randomized single-blind comparative parallel group study of the safety, pharmacokinetics and pharmacodynamics of GNR-086 and Ilaris® in healthy volunteers. Participants received a single subcutaneous dose of canakinumab 150 mg. The follow up period was 120 days.

2022-09-06

2023-03-17

2023-05-26

Completed

Early phase I

105

Inclusion Criteria: * Written informed consent to participate in the study, obtained from the volunteer before the start of any procedures related to the study; * Men and women aged 18 to 45 years, inclusive, at the time of signing the informed consent form; * Verified diagnosis "healthy" (the diagnosis "healthy" is established on the basis of a detailed medical history, in the absence of deviations from normal values during a clinical examination, including measurement of blood pressure, heart rate, respiratory rate, body temperature, as well as laboratory data studies, results of electrocardiography and fluorography); * Body weight from 50 to 85 kg, body mass index from 18.5 to 28 kg/m2, inclusive. * Agreement to adhere to adequate methods of contraception during the entire period of participation in the study or for 3 months after administration of the study or reference drug in case of early termination of participation in the study. Exclusion Criteria: * Severe chronic diseases, history of seizures; * Acute infectious diseases less than 4 weeks before administration of the study or reference drug; * Any history of chronic or recurrent infectious diseases; * History of tuberculosis; * Vaccination with any vaccine within 3 months before the administration of the study or reference drug or planned for the period of the volunteer's participation in the study; * Compounded allergy history; history of hypersensitivity to the active substance or other components of the study or reference drug; * Pregnancy or breastfeeding period; * Special lifestyle (work at night, extreme physical activity); * Deviations of vital signs: systolic pressure less than 100 mm Hg. Art. or more than 130 mm Hg. Art.; diastolic pressure less than 60 mm Hg. Art. or more than 90 mm Hg. Art.; heart rate less than 60 beats/min or more than 90 beats/min; * Dehydration due to diarrhea, vomiting, or other cause within 24 hours prior to administration of the study or reference drug; * Taking prescription medications within 28 days or 5 half-lives (whichever is longer) or taking over-the-counter medications/dietary supplements within 14 days prior to study or reference drug administration (occasional use of paracetamol at any time prior to study drug administration is acceptable) or reference drug); * Blood donation or blood loss (450 ml of blood or more) less than 3 months before the administration of the study or reference drug and/or blood donation in any quantity planned for the period of the volunteer's participation in the study; * Participation in clinical trials of medicinal products (less than 3 months or 5 half-lives from the study drug, whichever is longer) before administration of the investigational or reference drug of this study; * Regular alcohol consumption exceeding 5 units. alcohol per week (where each unit is equal to 30 ml of ethyl alcohol or 325 ml of beer), or information about a history of alcoholism, drug addiction, or drug abuse; * Positive test for the presence of alcohol in exhaled air; * Smoking more than 5 cigarettes per day for 3 months before this study; * Positive urine test for the content of narcotic and potent drugs; * Positive test for hepatitis B, C, HIV or syphilis; * Any surgical interventions planned during the period of participation in the study; * Unwillingness or inability to comply with the requirements of this protocol.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 105, 'type': 'ACTUAL'}}

2024-07-01