Tolyatti

Researchers are evaluating the effectiveness, safety, and tolerability of the drug 4-MUST at different doses compared to a placebo in adults aged 18 to 70 years with chronic cholecystitis and biliary dyskinesia. This Phase 2 study focuses on patients experiencing pain or discomfort in the upper abdomen along with other digestive symptoms such as heartburn, nausea, bloating, or changes in bowel habits. The goal is to see how well 4-MUST reduces upper abdominal pain and improves gastrointestinal symptoms. Participants receive either 4-MUST tablets containing 128 mg of trimebutine 4-methylumbelliferyl sulfate or placebo tablets. The study compares various doses of 4-MUST to placebo in parallel groups under double-blind conditions, meaning neither doctors nor patients know which treatment is given. The treatments are administered over a period that allows assessment of pain relief and safety. During the study, participants will be assessed for changes in upper abdominal pain severity using a visual analog scale by day 29 compared to baseline. Researchers will monitor safety and tolerability through questionnaires and clinical evaluations. Women must use effective contraception or meet specific reproductive criteria, and all participants will provide informed consent. The study includes careful monitoring for compliance, adverse events, and other health conditions that might affect participation or outcomes.

Researchers are evaluating the pharmacokinetics, pharmacodynamics, long-term efficacy, and safety of olokizumab in children and adolescents aged over 2 and under 18 years with polyarticular juvenile idiopathic arthritis. This open-label, multicenter Phase 2 study aims to better understand how olokizumab behaves in the body and its effects in this young patient population. Participants receive subcutaneous injections of olokizumab every 4 weeks, with doses adjusted by weight (either 64 mg or 48 mg). The study includes a screening period of up to 2 weeks, followed by 24 weeks of open-label treatment, then an extended open-label treatment period lasting up to 140 weeks, and finally a safety follow-up period of 22 weeks. The total study duration for participants is approximately 188 weeks. During the study, up to 50 patients will be closely monitored through scheduled visits and assessments. Researchers will measure olokizumab concentration levels in the blood, track clinical outcomes, and evaluate safety throughout the treatment and follow-up periods. They will also assess disease activity, laboratory tests, and adverse events to gather comprehensive data on the medication's performance and participant health over time.

Researchers are evaluating the safety, tolerability, and effectiveness of the drug tenofovir alafenamide (TAF) compared to a placebo in children and teenagers who have chronic hepatitis B virus (CHB) infection. The study aims to understand the appropriate dosing levels for children and teens and is conducted as a Phase 2 clinical trial. Participants include males and females who meet specific health and laboratory criteria related to their hepatitis B infection. Participants are randomly assigned to receive either TAF or a placebo, both administered orally once daily. The study involves different cohorts based on weight to assess dosing accurately. The treatment and monitoring phases last up to 24 weeks, during which the drug's effects and safety are closely observed. The study also collects pharmacokinetic data to understand how the drug behaves in the body over time. During the study, participants will undergo regular evaluations including blood tests to measure hepatitis B viral levels and liver enzymes, electrocardiograms (ECGs) to monitor heart function, and safety assessments for any adverse events. Researchers will track how many participants experience serious or any adverse events by week 24, as well as the percentage of participants achieving low levels of hepatitis B virus in their blood. The study requires informed consent and ongoing cooperation from participants and their guardians throughout the trial duration.