Moscow', Russian Federation

A Safety and Pharmacokinetics Study of Complarate (Tocilizumab Biosimilar Solution) and Actemra® in Healthy Volunteers

Complarate (tocilizumab, solution) is being developed as a biosimilar to the drug Actemra®, a solution for subcutaneous injection. Tocilizumab is a recombinant humanized monoclonal antibody to the human interleukin-6 (IL-6) receptor from the immunoglobulin G1 (IgG1) subclass. Tocilizumab binds to and inhibits both soluble and membrane IL-6 receptors (sIL-6R and mIL-6R). This I phase study is aimed to compare the pharmacokinetics and safety of the drugs Complarate and Actemra® after their single subcutaneous administration to healthy volunteers at a dose of 162 mg. The study included healthy volunteers aged 18-45 years at the time of signing the informed consent form. The study included a screening period, single administration of study/comparator drug and a follow up period. Allocation of patients to treatment groups was carried out by randomization in a ratio of 1:1 to the study drug and comparator drug. 256 patients (128 to the study drug group and 128 to the comparator drug group) are being randomized.

An Efficacy and Safety Study of GNR-086 (canakinumab Biosimilar) and Ilaris® in Patients with Adult-onset Still's Disease

GNR-086 is being developed as a proposed biosimilar to Ilaris®, a lyophilisate for the preparation of a solution for subcutaneous administration. Canakinumab is a fully human monoclonal antibody of the immuniglobulin G1 (IgG1(kappa)) isotype that binds specifically and with high affinity to interleukin-1β (IL-1β). Canakinumab, by binding to human IL-1β, blocks the interaction of this cytokine with its receptors, thereby functionally neutralizing the biological activity of this cytokine, without preventing either the binding of the natural inhibitor IL-1Ra, or the binding of IL-1α to IL-1 receptors. IL-1β is recognized as one of the main pro-inflammatory cytokines in various inflammatory conditions. This III phase study is aimed to compare the efficacy, safety and immunogenicity of GNR-086 and Ilaris®. The study will enroll patients with the confirmed diagnosis of adult-onset Still's disease in accordance with the classification criteria of Yamaguchi M. et al. (J. Rheumatology, 1992), and the duration of the disease at least 2 months before inclusion into the study. 148 paitnts will be randomised 2:1 to receive either GNR-098 or Ilaris®. Participants will receive canakinumab 4 mg/kg suncutaneously every 4 weeks for 24 weeks following the study extension.

Efficacy, Safety, and Tolerability of 4-MUST Tablets in Chronic Cholecystitis and Biliary Dyskinesia

Efficacy and Safety of Ranquilon in Patients With Anxiety Disorders Due to Neurasthenia and Adaptation Disorders

Study to Evaluate the Efficacy and Safety of Using Different Doses of Graminidin With Anesthetic for the Treatment of Acute Infectious-inflammatory Diseases of the Pharynx in Comparison With Septolete Total, Lozenges

Safety, Tolerability, and Pharmacokinetic Parameters of Grammidin, a Metered Spray in Healthy Volunteers

The Efficacy and Safety of Raphamin in the Treatment of Acute Rhinosinusitis in Adult Patients

A multicenter, double-blind, placebo-controlled, randomized, parallel-group clinical trial. The trial will enroll outpatients of either gender aged 18 to 75 years with clinical manifestations of acute rhinosinusitis (ARS) within the first 48 hours after the disease onset. Patient recruitment will be conducted during the seasonal incidence of acute respiratory viral infection (ARVI). After the patient signs the information sheet and informed consent form for participation in the clinical trial, the medical history will be collected, thermometry, objective examination, laboratory tests will be performed, concomitant diseases and concomitant therapy will be recorded. The severity of ARS symptoms will be assessed using Major Symptom Score (MSS). Initially (Day 1) and on Visits 2 (Day 4) and 3 (Day 7), the patient together with the investigator, fills in the MSS scale and completes the Sino-Nasal Outcome Test questionnaire for assessing the quality of life of patients with diseases of the nose and paranasal sinuses (SNOT-22). If all inclusion criteria are met and there no any exclusion criteria, at Visit 1 (Day 1), the patient is randomized into one of two groups: Group 1 patients will receive Raphamin according to the dosage regimen for 5 days; Group 2 patients will receive Placebo using the Raphamin dosage regimen for 5 days. The trial uses an electronic patient diary (EPD) where the patient daily morning and evening will make records axillary body temperature (measured with a classic mercury-free thermometer) and symptoms of the disease (according to the MSS). In addition, administration of basic therapy drugs (if applicable) as well as any possible worsening of the patient's condition (if applicable, to assess safety / to record adverse events) should also be recorded in the patient diary. The investigator will instruct the patient on how to complete the diary. At Visit 1, the patient will record the severity of ARS symptoms and body temperature in the diary together with the physician. The patient will be observed for 14 days (screening, randomization - up to 1 day, treatment - 5 days, follow-up - up to 14 days). During the treatment and follow-up period, patients/physicians will pay 3 visits, on days 1, 4 and 7 (Visits 1, 2 and 3) - at a medical center or at home; a phone visit (Visit 4) will be on day 14. At Visits 2 and 3, the investigator performs objective examination, records changes in the disease symptoms, concomitant therapy, and controls the filling of the diary, evaluates the patient's compliance (Visit 3). At Visit 4 (a phone visit), the investigator evaluates safety, collects information about the patient's condition, the presence/absence of complications, the use of antibiotics, and the presence/absence of hospitalization of the patient. Symptomatic therapy and therapy for concomitant diseases will be permitted during the trial except for the drugs listed under "Prohibited Concomitant Treatment".

An Open-Label, Comparative Study of the Efficacy, Safety and Pharmacodynamics of Single Dose of ANB-002 in Patients With Hemophilia B

After signing the ICF and screening examination the subjects are to be included in the Non-interventional lead-in period in which the subject will receive standard FIX prevention. The lead-in period will last for at least 6 month for every subject. After completiong the lead-in period subjects will enter the main (interventional) period. At the first visit of the main period subjects will recieve investigational product ANB-002. The main period ends 18 months after the administration of ANB-002, after which subjects will switch to the follow-up period and will be evaluated up to 5 years after the ANB-002 infusion.

Clinical Trial of the Efficacy and Safety of Raphamin in the Treatment of ARVI in Children Aged 3-12 Years

Design: a multicenter, double-blind, placebo-controlled, randomized, parallel-group clinical trial. The trial will enroll outpatients of either gender aged 3 to 12 years with clinical manifestations of acute respiratory viral infection (ARVI) within the first 24 hours after the disease onset. Patient enrollment will be conducted in 2 stages during the seasonal incidence of ARVI. First, children aged 6-12 years will be enrolled in the trial. Once the required number of patients is reached, an "unblinded" interim analysis with the primary efficacy endpoint assessment and safety analysis will be performed. Based on the data from the unblinded interim analysis, a decision will be made whether the age range of enrollment can be expanded from 3 to 12 years. Patient enrollment will not be stopped until the results of the "unblinded" interim analysis are available. After the parent/adopter signs the information sheet and informed consent form for the patient's parents/adopters to participate in the clinical trial, the medical history will be collected, thermometry, objective examination, laboratory tests will be performed, and concomitant therapy will be recorded. The severity of ARVI symptoms will be assessed using a 4-point scale. The nasopharyngeal swabs for PCR diagnosis and verification of respiratory viruses will be performed prior to therapy to confirm the viral etiology of ARVI. If a patient meets all inclusion criteria and does not have any exclusion criteria, at Visit 1 (Day 1), they will be randomized into one of two groups: Group 1 patients will receive Raphamin according to the dosage regimen for 5 days; Group 2 patients will receive Placebo using the Raphamin dosage regimen for 5 days. The trial will utilize an electronic patient diary (EPD) where the patient will make daily records of morning and evening axillary body temperature (measured with a classic mercury-free thermometer) and symptoms of the disease (ARVI Symptom Severity Score). In addition, antipyretic dosing (if applicable) as well as any possible worsening of the patient's condition (if applicable, to assess safety / to record adverse events) will also be recorded in the patient diary. The investigator will instruct the parent/adopter on how to complete the diary. At Visit 1, the parent/adopter together with the physician will record the severity of ARVI symptoms and body temperature in the diary. The patient will be observed for 14 days (screening, randomization - up to 1 day, treatment - 5 days, follow-up - up to 2 days; deferred "phone visit" - day 14). During the treatment and follow-up period, patients/physicians will pay 3 visits, and the fourth "phone visit" will be scheduled additionally: 1) physician/patient visits - on days 1, 5 and 7 (Visits 1, 2 and 3) - at the health center or at home; 2) a phone "visit" by the physician (Visit 4) - on day 14. During Visits 2 and 3, the physician will perform objective examination, record changes in the disease symptoms, concomitant therapy, and monitor the completion of the diary. During Visit 3, compliance will be assessed and laboratory tests will be performed. A phone "visit" will be performed to interview the parent/adopter about the patient's condition, presence/absence of secondary bacterial/viral complications, and use of antibiotics. Symptomatic therapy and therapy for concomitant diseases will be permitted during the trial except for the drugs listed under "Prohibited Concomitant Treatment".

An Open-Label Clinical Study of the Efficacy and Safety of BCD-248 in Patients with Relapsed/Refractory Multiple Myeloma